WO2002025995A1

WO2002025995A1 - Method for producing otoplastics

Info

Publication number: WO2002025995A1
Application number: PCT/CH2000/000524
Authority: WO
Inventors: Christoph Widmer; Hans Hessel; Markus Weidmann
Original assignee: Phonak Ag
Priority date: 2000-09-25
Filing date: 2000-09-25
Publication date: 2002-03-28
Also published as: EP1323331B1; AU2000272659B2; EP1323331A1; CA2424835C; AU7265900A; CA2424835A1

Abstract

The aim of the invention is to take account of the dynamics of the area to which a hearing aid is applied, for example the auditory canal. To this end, this area is reproduced in several positions that are adopted by the area as part of its dynamics. With computer assistance (97), these reproductions are then used to optimise the mould or the mould behaviour of the hearing aid shell.

Description

Process for the production of earmolds

The present invention relates to a method for producing earmolds according to the preamble of claim 1 and to the use of this method according to the wording of claim 6.

The present invention is based on problems that have arisen primarily in the production of in-the-ear hearing aids. However, the resulting solution can basically be applied to the manufacture of all otoplastics, which - as will be described later - are arranged or applied in a dynamic application area.

In-the-ear hearing aids are usually produced today, for example, by making an impression of the auditory canal of an individual concerned, for example by the audiologist, and sending this to the company producing the hearing aid, where, according to the impression, the hearing aid shell is created. Due to e.g. Diagnostic data, likewise determined by the audiologist, is assembled with the hearing aid shell using the corresponding electronic modules.

It is extremely important, especially with the relatively hard hearing aid shell materials used today, that the outer shape of the hearing aid is exactly adapted to the individual ear canal shape. This usually requires further trials of the finished hearing aid and a fine adjustment of the shape of the hearing aid.

BESTATIGUNGSKOPIE With all these efforts to achieve the highest possible wearing comfort for the hearing aid, the lively dynamics of the ear canal, for example during the buying process, cannot be taken into account with such a procedure, because the impression is only a snapshot of the ear canal configuration at a certain position of the jaw.

It is the object of the present invention to propose a method of the type mentioned at the outset, by means of which the above-mentioned problem is solved. For this purpose, it is proposed to register a three-dimensional image of the application area at at least two positions of its movement and to use this registration to optimize the design of the otoplastic with regard to the moving application area.

In a simplest embodiment of the method according to the invention, not necessarily the least complex, at least two impressions, preferably more than two impressions, are taken from the application area of the otoplastic - in the case of an in-ear otoplastic or an in-the-ear hearing aid, the ear canal , with several positions of the jaw and thus of the ear canal occurring in the chewing movement. With the help of these registrations, either the otoplastic shell, initially assumed to be rigid, is shaped in such a way that it at least disturbs the chewing movements that occur and nevertheless meets the requirements regarding positional positioning in the ear canal or on the application area. In a further embodiment of the method according to the invention, the design of the otoplastic is carried out with the aforementioned registration optimized with regard to their shape behavior, ie with regard to their bending and compression properties.

These optimizations are preferably modeled with the aid of computers. The three-dimensional, digitized data corresponding to the model found to be optimal are subsequently used to control the further manufacturing process, in particular the shell forming.

Instead of the complex formation of several impressions of the application area - in the case of in-ear earmolds of the auditory canal - it is proposed to record the dynamics of the application area with more than two registrations, practically film-like, for example on the basis of X-ray recordings or by means of in-ear video recordings mimic. As mentioned, in a preferred embodiment of the method according to the invention, the application area is mapped at more than two positions, that is to say at several positions, in order to cover the entire dynamic range of the application area that occurs in everyday life. In one embodiment of the method according to the invention, the registrations optimize the outer shape of the otoplastic. As has been mentioned, this is mainly used when using relatively hard otoplastic shell materials or as a basic setting for a subsequent one

Refinement of the optimization taking into account areas to be planned, bendable or compressible on the otoplastic. It is therefore also proposed that the registrations optimize the shape behavior of the otoplastic, that is to say where and how the otoplastic and, in particular, in the case of intended internals, its shell should be bendable or compressible. In a preferred embodiment of the method according to the invention, the design of the otoplastic is carried out by means of arithmetic optimization, and the arithmetic configuration is found to be optimal

Production of the earmold controlled. The method according to the invention is particularly suitable for the production of in-ear earmoulds, in particular in-ear hearing aids, but also for headphones, hearing protection devices such as noise protection devices or water protection devices. However, it can also be used for the exact adaptation of outer ear earmolds, in particular outer ear hearing aids.

The invention is subsequently explained, for example, with reference to figures of otoplastics for which the proposed method according to the invention is suitable and a representation of the method according to the invention or a device for carrying it out. These show for example:

1 shows a simplified diagram of a manufacturing plant for the optimization of industrial manufacturing of earmolds;

Fig. 2 in a representation analogous to that of Fig. 1, a further system concept;

FIG. 3 shows a still further system concept in a representation analogous to that of FIGS. 1 and 2;

4 schematically shows an in-the-ear hearing device with a cerumen protective cap fitted in a known manner; 5 shows a representation analogous to FIG. 4, an in-the-ear hearing aid made with a cerumen protective cap;

6 shows an in-the-ear hearing aid with a ventilation groove incorporated in a known manner;

7 (a) to (f)

cutouts of otoplastic shell surfaces shown in perspective, with ventilation grooves;

8 shows a ventilation groove with a cross-section or cross-sectional shape that varies along its length, using a schematic section of an otoplastic surface;

9 schematically shows an in-ear otoplastic with an extended ventilation groove;

FIG. 10 shows a representation analogous to FIG. 9, an in-ear otoplastic with a plurality of ventilation grooves;

11 (a) to (e)

Cutouts of otoplastic shells with integrated ventilation channels of various cross-sectional shapes and dimensions;

FIG. 12 shows, in a representation analogous to that of FIG. 8, a ventilation channel in an otoplastic shell with a cross-sectional shape or cross-sectional area that varies along its longitudinal extent; FIG. 13 in analogy to the representation of FIG. 9, schematically an in-ear earmold with an integrated, elongated ventilation channel;

FIG. 14 shows a representation analogous to FIG. 10, an in-ear otoplastic with a plurality of ventilation channels;

15 schematically shows a longitudinal sectional view of an in-ear earmold with a ribbed inner surface;

16 shows a detail of the otoplastic according to FIG. 15 in cross section, the ribs having different cross-sectional areas;

Fig. 17 shows the perspective of a section

15 or 16, wherein the ribs have different cross-sectional shapes and dimensions along their longitudinal extent;

FIG. 18 shows a representation analogous to FIG. 15, an in-ear otoplastic with external ribbing;

19 schematically shows a section of an otoplastic shell with ribs according to FIG. 18 with ribs of different cross-sectional areas;

Fig. 20 schematically shows a cross section through a

Otoplastic with external ribbing, possibly internal ribbing, and at least partially filler-filled interior;

21 schematically shows a longitudinal section of an otoplastic shell with a flexible and compressible portion; 22 schematically shows in longitudinal section an in-the-ear otoplastic with a receiving space for an electronic module;

23 the otoplastic according to FIG. 22 when it is put over an electronic module;

24 is a perspective and schematic view of an in-ear otoplastic, such as in particular an in-the-ear hearing aid, with a two-part, separable and assemblable otoplastic shell;

25 shows, in sections and schematically, the integration of acoustic conductors and adapter elements to form an acoustic / electrical or electrical / acoustic transducer in an otoplastic;

FIG. 26 shows a representation analogous to that of FIG. 25, the arrangement of two or more acoustic conductors in the shell of an otoplastic shell, and

Fig. 27 using a simplified

Signal flow / functional block diagram, the method according to the invention and an arrangement according to the invention for its execution, in which the dynamics of the

Application area of an earmold is taken into account for its shaping.

Those described after the manufacturing process

Embodiments of otoplastics are preferably all manufactured using the manufacturing method described. definition

We understand an otoplastic to be a device that is applied directly outside the auricle and / or on the auricle and / or in the ear canal. These include outer ear hearing aids, in-the-ear hearing aids, headphones, noise protection and water protection inserts etc.

1. Manufacturing process

The manufacturing process, which is preferably used to manufacture the otoplastics described in detail below, is based on three-dimensionally digitizing the shape of an individual application area for an intended otoplastic, then creating the otoplastic or its shell using an additive assembly process. Additive construction processes are also known under the term "rapid prototyping".

With regard to such additive processes already used in rapid prototype construction, e.g. referred to:

• http://ltk.hut.fi/~koukka/RP/rptree.html (1)

or on • Wohlers Report 2000, Rapid Prototyping

& Tooling State of the industry (2)

From the group of these additive processes known today for rapid prototype construction, it follows that laser sintering, laser or stereolithography or that

Thermojet processes are particularly well suited to building up earmoulds or their shells, and in particular the special embodiments described below. Therefore, to summarize only briefly, the specifications of these preferred additive assembly processes are discussed:

• Laser sintering: Hot melt powder is applied to a powder bed, for example using a roller, in a thin layer. The powder layer is solidified by means of a laser beam, the laser beam and others. is controlled according to a cut layer of the otoplastic or otoplastic shell by means of the 3D shape information of the individual application area. A solidified cut layer of the otoplastic or its shell is formed in the powder, which is otherwise loose. This is lowered from the powder laying level and a new powder layer is applied over it, which in turn is laser-hardened in accordance with a cut layer, etc.

• Laser or stereolithography: A first cut layer of an otoplastic or an otoplastic shell is solidified on the surface of liquid photopolymer by means of a UV laser. The solidified layer is lowered and is again covered by liquid polymer. By means of the UV laser mentioned, the second cut layer of the otoplastic or its shell is solidified on the already solidified layer. Again, the laser position control takes place, among other things, by means of the 3D data or information of the individual, previously recorded application area. 2/25995

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Thermojet process: The contour formation corresponding to a cut layer of the otoplastic or the otoplastic shell is carried out similarly to an ink jet printer by means of liquid application, etc. carried out in accordance with the digitized 3D shape information, in particular also the individual application area. Then the filed section "drawing" is solidified. Again, in accordance with the principle of the additive build-up method, layer by layer is deposited to build up the otoplastic or its shell.

With regard to additive construction methods and the above-mentioned preferred publications, reference may be made to the following further publications:

• http://www.padtinc.com/srv__rpm_sls.html (3)

"Selective Laser Sintering (SLS) of Ceramics", Muskesh Agarwala et al. , presented at the Solid Freeform Fabrication Symposium, Austin, TX, August 1999, (4)

• http://www.caip.rutgers.edu/RP__Library/process.html (5)

• http://www.biba.uni-bremen.de/groups/rp/lom.html or

• htt: // ww .biba.uni-bremen .de / groups / rp / rp__intro.html

(6)

• Donald Klosterman et al. , "Direct Fabrication of Polymer Composite Structures with Curved LOM", Solid Freeform Fabrication Symposium, University of Texas at Austin, August 1999, (7)

• http://lff.me.utexas.edu/sls.html (8) • http://www.padtinc.com/srv_rpm__sla.html (9)

• http://www.cs.hut.fi/~ado/rp/rp.html (10)

Basically, a thin layer of material is deposited on a surface in additive build-up processes, be it like laser sintering or

Stereolithography over the entire surface, be it in the contour of a cut of the otoplastic or its shell, which is under construction, as in the thermojet process. The desired cut shape is then stabilized or consolidated.

Once a layer has solidified, a new layer is placed over it as described and this in turn is solidified and connected to the already finished layer underneath. The otoplastic or its shell is created layer by layer by additive layer-by-layer application.

For industrial production, it is preferred not only to lay down or solidify the cut layer for an individual earmold or its shell, but also several individual ones at the same time. at

Laser sintering, for example, one laser, usually mirror-controlled, successively solidifies the cut layers of several otoplastics or their shells before all the solidified cut layers are lowered together. Thereupon, after a new powder layer has been deposited over all the already solidified and lowered cut layers, the formation of the several further cut layers takes place again. Despite this parallel manufacturing the respective earmolds or their shells, digitally controlled, individually manufactured.

Either a single laser beam is used to solidify the multiple cut layers and / or more than one beam is operated and controlled in parallel.

An alternative to this procedure is to solidify a cut layer with a laser, while at the same time the powder layer is deposited for the formation of a further otoplastic or otoplastic shell. Then the same laser will solidify the prepared powder layer according to the cut layer for the further plastic, while the layer solidified in front of it is lowered and a new powder layer is deposited there. The laser then works intermittently between two or more earmolds or otoplastic shells being built up, the dead time resulting from the powder deposit during the formation of one of the shells being used to solidify a cut layer of another earmold being built up.

1 schematically shows how, in one embodiment variant, several otoplastics or their shells are manufactured industrially in a parallel process by means of laser sintering or laser or stereolithography. The laser with control unit 5 and beam 3 is mounted above the material bed 1 for powder or liquid medium. In position 1 it solidifies the layer S _{x of} a first earmold or its shell, controlled with the first individual data set Di. Then it is adjusted to a second position on a displacement device 7, O 02/25995

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where he creates the layer S ₂ according to a further individual contour with the individual data set D ₂ . Of course, several of the lasers can be moved as a unit and more than one individual otoplastic layer can be created at the same time. Only when the envisaged lasers 5 have created the respective individual layers in all envisaged positions is a new powder layer deposited with the powder feed shown generally at 9 in the case of laser sintering, while (not shown) during the laser or

Stereolithography the solidified layers S are lowered in the fluid bed.

According to FIG. 2, layers of individual earmolds or their shells are solidified simultaneously on one or more liquid beds 1 or powder beds 1, with several simultaneously individually controlled lasers 5. Once again, a new powder layer is deposited with the powder dispensing unit 9 after completion of this solidification phase and after the laser has been stopped, while in the case of laser or stereolitography the layers which have just been solidified or structures which have already been solidified are lowered in the fluid bed.

According to FIG. 3, laser 5 solidifies layer Si on a powder or liquid bed la, in order to then switch to bed lb (dashed line), which is indicated during the

Solidification phase at the bed la the powder application device 9b ablates or on a previously solidified layer Sι_ powder is lowered in the laser or stereolithography, the layer S _x _. Only when the laser 5 becomes active on the bed 1b does the powder dispenser 9a take place depositing a new powder layer over the layer S _x just solidified on the bed la or lowering the layer Si in the liquid bed la.

When using the Thermojet process and for increasing productivity, cut layers of more than one earmold or its shells are deposited at the same time, practically in one drawing by an application head or, in parallel, by several.

The method shown makes it possible to implement highly complex shapes on otoplastics or their shells, both in terms of their outer shape with individual adaptation to the application area and also in the case of a shell whose inner shape is concerned. Overhangs, jumps and jumps can be easily realized.

In addition, materials for additive construction processes are known which can be formed into a rubber-elastic and yet dimensionally stable shell which, if desired, can be realized locally differently up to extremely thin-walled and nevertheless tear-resistant.

In a preferred embodiment today, the digitization of the individual application area, in particular the application area for a hearing device, in particular in-the-ear hearing device, is carried out at a specialized institution, in the latter case at the audiologist. The individual form recorded there, as digital 3D information, is transmitted to a production center, in particular in connection with hearing aids, be it by transmission of a data carrier, be it through an Internet connection, etc. In the production center, in particular using the methods mentioned above, the otoplastic or its shell, in the case under consideration, ie the in-the-ear hearing aid shell, is individually shaped. The finished assembly of the hearing device with the functional assemblies is also preferably carried out there.

Due to the fact that, as mentioned, the thermoplastic materials used generally lead to a relatively elastic, conforming outer shape, the shape with regard to pressure points in otoplastics or their shells is far less critical than was previously the case, which in particular is of crucial importance for in-ear earmolds. For example, in-ear earmolds can be used as

Hearing protection devices, headphones, water protection devices, but in particular also for in-the-ear hearing aids, are used, similar to rubber-elastic plugs, and their surface conforms optimally to the application area, the ear canal. It is easily possible to incorporate one or more ventilation channels into the in-ear earmold in order to ensure unimpaired ventilation to the eardrum when the earmold is seated in the ear canal, which may be relatively tight. With the individual 3D data of the application area during production, the interior of the plastic can also be optimized and optimally used, also individually with regard to the individual unit constellation to be recorded, such as with a hearing aid. In particular in the case of otoplastics in the form of hearing aids, the central production of their shells enables central storage and management of individual data, both with regard to the individual application area and also the individual functional parts and their settings. If, for whatever reason, a shell needs to be replaced, it can easily be made again by calling up the individual data records, without the need for laborious readjustment - as was the case up to now.

Due to the fact that the methods described for the production of earmolds, but only for prototype construction, are known and are described in the literature, it is not necessary at this point to reproduce all the technical details relating to these methods.

In any case, surprisingly, the adoption of these technologies known from prototype construction for the industrial, commercially viable manufacture of earmolds results in very significant advantages, namely from

Reasons that, in themselves, are not decisive in prototype construction, e.g. Elasticity of the usable thermoplastic materials, the possibility to build extremely thin walls individually etc.

In summary, the use of the additive assembly processes mentioned for the production of earmolds and / or their shells makes it possible to integrate various functional elements into them, which are already structurally prepared on the computer during the planning of the earmold and which involve the assembly of the earmold or their shell are generated. Typically, functional elements of this type have so far only been fitted into or added to the otoplastic or its shell after the completion of the otoplastic, which can be recognized from material interfaces or material inhomogeneity at the connection points.

For the otoplastics mentioned, in particular with electronic internals, such as for hearing aids, in particular for in-the-ear hearing aids, there are elements which can be directly incorporated into the proposed technology

Otoplastic shell can be installed, for example: mounts and holders for components, cerumen protection systems, ventilation channels in in-ear earmolds, support elements which hold the latter in the ear canal in in-ear earmolds, such as so-called claws (English channel locks).

4 shows, for example and schematically, an in-ear earmold 11, for example an in-ear hearing device, in which the acoustic output 13 to the eardrum is protected by a cerumen protective cap 15. Up to now, this protective cap 15 has been applied to the shell 16 of the otoplastic 11 as a separate part and fixed, for example by gluing or welding. As shown in FIG. 5 in the same representation, the cerumen protective cap 15a is integrated directly onto the shell 16a of the otherwise identical in-ear earmold 11a by using the additive construction methods mentioned. At the connection points indicated schematically by P in FIG. 4, where in conventional methods a material 5 there are no such interfaces, the material of the shell 16a merges homogeneously with that of the cerumen protective cap 15a.

This is only an example of how well-known cerumen protection systems and other functional elements can be integrated using the aforementioned manufacturing process.

Some specific new types of earmolds are presented below:

2. Inner ear earmolds with ventilation

It is known to provide a ventilation channel on the outside of in-ear earmolds, in particular in-oh hearing aids, as is shown schematically in FIG. 6. Such ventilation channels, as they are used today, are in no way optimized in various ways:

- Regarding acoustic behavior: The ventilation channels known today are hardly adapted to the respective acoustic requirements. In active earmolds, such as in-the-ear hearing aids, they can hardly help to effectively solve the feedback problem from the electromechanical output transducer to the acoustic / electrical input transducer. Even with passive in-ear earmolds, such as hearing protection devices, they are unable to support the desired protective behavior and at the same time maintain the desired ventilation properties. - Cerumen sensitivity: The ventilation channels used today in the outer surface of in-ear earmolds are extremely sensitive to cerumen formation. Depending on their intensity, the cerumen formation can quickly, if not completely, block the ventilation channels provided with regard to their ventilation properties.

In the following, ventilation measures are proposed for in-ear earmolds, in particular for in-the-ear hearing aids or hearing protection devices, but also for otoplastics that only partially protrude into the ear canal, such as headphones, which at least partially remedy the above-mentioned disadvantages of known measures.

To this end, a distinction is made between ventilation systems that

- are at least partially open against the wall of the ear canal,

- Are completely closed against the wall of the ear canal.

2a) Ventilation systems open against the wall of the ear canal

7 (a) to (f), with the aid of perspective, schematic representations of sections of the outer wall 18 of in-the-ear earmoulds adjacent to the auditory canal, sections of novel ventilation groove profiles are shown. 7 (a), the profile of the ventilation groove 20a is rectangular or square with specified, exactly maintained dimensioning ratios. 7 (b), the profile of the ventilation groove 20b is circular or elliptical sector-shaped, again with an exactly predetermined cross-sectional boundary curve 21b. By exact specification and implementation of the

The cross-sectional shape of the ventilation grooves 20 provided can already achieve a certain degree of predictability and influence on the acoustic transmission conditions along this groove, if they are in contact with the inner wall of the auditory canal. Of course, the acoustic behavior is also dependent on the length with which the groove 20 extends along the outer wall 18 of the otoplastic.

7 (c) to (f) show further ventilation groove profiles which are additionally protected against cerumen. The profile of the groove 20c according to Fig. 7 (c) is T-shaped.

With regard to the wide groove cross-sectional area at 27c, the projecting portions 23c and the resulting narrowing 25c, towards the wall of the ear canal, already have a considerable cerumen protection effect. Even if cerumen penetrates into the constriction 25c and hardens there, this does not result in any significant constriction or even blockage of the ventilation groove, which is now a closed ventilation channel. 7 (d) to 7 (f), following the explained principle of FIG. 7 (c), the cross-sectional shape of the wide groove part 27d to 27f is formed with different shapes, ge ass. 7 (d) circular sector or 7 according to the sector of an ellipse, according to FIG. 7 (e) triangular, ge ass FIG. 7 (f) circular or elliptical. By specifically designing the cross-sectional area of the groove, as shown only with reference to FIGS. 7 (a) to 7 (f), it is possible to improve the acoustic properties as well as the wax protection effect to a great extent compared to conventional, more or less randomly profiled ventilation grooves Make an impact. The profiles are previously mathematically modeled taking into account the wax protection effect mentioned and the acoustic effect and are precisely integrated into the manufactured earmoulds. The additive construction methods explained above are particularly suitable for this. In order to further optimize the acoustic effect of the ventilation groove, a wide variety of acoustic impedances can be implemented along the novel ventilation grooves, which results, for example, according to FIG. 8 in ventilation grooves 29 which, progressing in their longitudinal direction, define different profiles, as can be seen in FIG 8 are shown assembled from profiles according to FIG.

Similar to the design of passive electrical networks, the acoustic transmission behavior of the groove in the ear canal can be mathematically modeled and checked, then integrated into the in-ear earmold or its shell.

Increasingly, cerumen-protected sections can be provided on exposed parts in this regard, as shown at A in FIG. 8.

Furthermore, it may well be desirable, especially with a view to optimizing the acoustic conditions provided ventilation grooves longer than is basically given by the longitudinal extent of a considered in-ear earmold. As shown in FIG. 9, this is achieved in that such grooves 31 with a configuration as are shown, for example, with reference to FIGS. 7 and 8 are guided in predetermined curves along the surface of the otoplastic, for example as shown in FIG. 9 , practical as grooves that wrap around the thread like an otoplastic. Further optimization flexibility is achieved in that not only one ventilation groove, but several are guided on the surface of the otoplastic, as is shown schematically in FIG. 10. The high flexibility of the groove design means that depending on the application area in the ear canal, different dimensions are targeted

Cerum protection and acoustic transmission conditions can be optimized ventilation grooves along the otoplastic surface.

2b) Ventilation systems with fully integrated channels

This variant of the new ventilation systems is based on ventilation channels that are completely integrated into the otoplastic at least in sections and closed against the wall of the ear canal. This system is then explained on the basis of its training on an otoplastic shell. It should be emphasized, however, that if no further units are to be integrated in the otoplastic in question and it is designed as a full plastic, the following explanations naturally also relate to a channel guide through the full plastic mentioned. Analogous to FIG. 7, FIG. 11 shows different cross-sectional shapes and area ratios of the proposed ventilation channels 33a to 33e. 11 (a), the ventilation duct 33a built into the otoplastic shell 35a has a rectangular or square shape.

Cross-sectional shape. In the embodiment according to FIG. 11 (b), it, 35b, has a circular sector or elliptical sector-shaped channel cross-sectional shape. In the embodiment according to FIG. 11 (c), the provided ventilation duct 33c has a circular or elliptical cross-sectional shape, while it is shown in FIG

11 (d) has a triangular cross-sectional shape.

In the embodiment according to Fig. 11 (e), the otoplastic shell has a complex internal shape, e.g. an integrated bracket 37. For optimal

The ventilation duct 35e provided here is designed with a cross-sectional shape that also uses complex shapes of the otoplastic shell. Accordingly, its cross-sectional shape extends, in part, in a complicated manner into the mounting strip 37 attached to the shell 35e.

Looking back at the design variant in accordance with section 2a), it should be stated that such complex cross-sectional shapes that optimally use the available space can also be implemented in ventilation grooves that are open towards the auditory canal, and vice versa, channel guides as used for open grooves in FIG. 9 and 10 are shown on closed ventilation channels.

Finally, FIG. 12 shows an embodiment variant of a fully integrated ventilation duct 39, which runs along its longitudinal extent, as shown for example in the otoplastic shell 41, has different cross-sectional shapes and / or cross-sectional dimensions, which can be used to optimize the acoustic transmission behavior in the sense of realizing different acoustic impedance elements. In this context and referring to the following section 5), it can also be pointed out that because of the possibility of realizing complex acoustic impedance conditions, ventilation channels, in particular the closed construction shown in this section, can be electromechanical at least in sections at the same time as acoustic conductor sections on the output side Transducers, as can be used on the output side of microphones, for example in in-the-ear hearing aids.

13 and 14, in analogy to FIGS. 9 and 10, show how, on the one hand, on the respective otoplastic 43, the integrated ventilation channels explained in this section are lengthened by appropriate web guidance, and on the other hand, like two or more of the channels mentioned, if necessary. with different and / or varying channel cross sections, analogous to FIG. 12, can be integrated on the otoplastic.

The possibilities shown in sections 2a) and 2b), which can be combined as required, open up a myriad of design variants of the new ventilation systems and, in particular, a large degree of freedom, due to the various parameters that can be dimensioned, for optimal wax protection for the respective individual otoplastic and optimal acoustic To create transfer relationships. In all variants, the specific individual configuration of the system is preferably calculated or modeled, taking into account the needs mentioned. Then the individual earmould is realized. Again, the manufacturing process explained at the beginning with an additive construction principle, as is known from prototype construction, is particularly suitable for this, which is then controlled with the optimized model result.

3. Shape stability-optimized earmolds

This section is about introducing new types of earmolds that are optimally adapted to the dynamics of the application areas. For example, it is known that conventional in-the-ear earmolds cannot take into account the relatively large ear canal dynamics, for example when chewing, due to their essentially identical shape stability. Likewise, for example, the acoustic conductors between the outer ear hearing aids and the auditory canal cannot freely follow a dynamic of the application area. The same problem arises with in-the-ear earmolds, partially weakened, also with hearing protection devices, headphones, water protection inserts, etc. In particular, their intrinsic function, for example protective action, is partially impaired if the mentioned application area dynamics are increasingly taken into account. As an example, reference can be made to known hearing protection devices made of elastically deformable plastics, which probably largely take into account the dynamic range of application mentioned, but this at the expense of their acoustic transmission behavior.

FIG. 15 schematically shows a longitudinal sectional view of an in-ear earmold, in FIG. 16 shows a schematic cross-sectional view of a section of this earmold. The earmold - e.g. for receiving electronic components - has a shell 45, which consists of stocking-like, thin-walled elastic material. The shape stability of the shell skin, which is smooth on the outside in the exemplary embodiment shown, is ensured, if desired, by ribs 47 which are integrally placed on the inside of the shell and which are made of the same material with respect to the shell skin.

Depending on the required dynamics of the in-ear earmold, on the one hand, for example to take account of those of the ear canal and the requirements with regard to the support and protection of internals, such as in the case of an in-the-ear hearing aid, the course of the wall thickness of shell skin 45, the density and shape of the ribs 47 are calculated beforehand and then the earmold is built up according to the calculated data. Again, the manufacturing method explained above using additive construction methods is extremely well suited for this. Of course, the design of the in-ear earmold just explained can be combined with a ventilation system, as was explained with reference to FIGS. 7 to 14. In particular, the ribs provided to influence the shape stability or bendability in certain areas of the otoplastic can also be formed with a different cross-sectional profile, if necessary also progressively progressing in length from one cross-section to another.

In the form of a perspective illustration, the formation of the outer skin 45 with ribs 47 with varying cross-sectional areas along its longitudinal extent is shown schematically in FIG.

Instead of or in addition to the targeted wall reinforcement and targeted design of the bending or torsion behavior, in short the shape behavior of the in-ear earmold, as mentioned, in addition to the inner rib pattern, as shown in FIGS. 17 and 18, one can also External rib patterning can be provided. According to FIGS. 18 and 19, a pattern of ribs 51 is worked up on the outer surface of the otoplastic 49, possibly with different density, orientation and profile shape.

According to FIG. 19, this can be used for the otoplastics with cavity considered here, but also for otoplastics with no cavity, for example with no electronic components, e.g. For

Hearing protection devices or water protection devices. Such an otoplastic is shown schematically in a cross-sectional illustration in FIG. 20. The interior 53 is made, for example, from extremely compressible absorption material and is surrounded by a shaping skin shell 55 with the rib pattern 57. "Skin" 55 and the rib pattern 57 are manufactured integrally together. The manufacturing method explained at the beginning with the aid of additive construction methods is again suitable for this. How far in the near future this additive assembly processes while changing the processed materials on a workpiece are not an option. If this becomes possible, the path is free, for example in the exemplary embodiment according to FIG. 20 also to build up the filler 53 simultaneously with the shell skin 55 and the ribs 57 in the respective structural layers.

Looking back in particular on FIGS. 18 and 19, it can be seen that with the aid of the outer rib patterns, ventilation channels or free spaces can be formed at the same time, as is shown purely schematically and, for example, by the path P.

Returning to FIG. 20, it is entirely possible, if necessary and as shown in dashed lines in FIG. 20 at 57i, even if the in-the-ear earmold is filled with material, that is, not to accommodate further structural units, such as electronic structural units. is intended to provide an inner rib pattern 57ι on the shell skin 55. As further shown in dashed lines in FIG. 20 at 59, otoplastics can also be created, which probably leave a cavity for receiving units such as electronic components, but in which the space between such a cavity 59 is specific to the necessary volumes and shapes of the designed additional units to be installed and the

Shell skin 55 is filled, for example, by a resilient or sound-absorbing material or components to be installed are poured out with such material as far as the shell skin 55. The shell skin 55 or 45, according to FIGS. 15, 16 and 17, can certainly be made of electrically conductive material, which at the same time creates an electrical shielding effect for internal electronic components. This may also apply to the filling 53 according to FIG. 20.

15 to 20, an otoplastic was shown using the example of an in-the-ear otoplastic, the shell of which is shape-stabilized with internal and / or external ribs, which results in an extraordinarily light and selectively formable construction. Of course, this design can also be used for outer ear earmolds if necessary.

FIG. 21 shows a further embodiment variant of an in-the-ear earmold which can be bent or compressed in a targeted manner. For this purpose, the shell 61 of an otoplastic, such as in particular the shell of an in-the-ear hearing device, has a corrugated or corrugated tube formation 63 in one or more predetermined areas, by means of which it can be bent or compressed in accordance with the respective requirements. Even if FIG. 21 shows this procedure using the shell of an in-ear earmold, this procedure can be implemented and if necessary also for an outer ear earmold. Again, the manufacturing method explained at the outset is preferably used for this purpose.

In this exemplary embodiment too, as was explained with reference to FIG. 20, the inner volume of the otoplastic can be filled with the filling material corresponding to the requirements or can be integrated therein Built-in components are embedded in such filling material, which results in greater stability of the device and improved acoustic conditions.

4. Modular housings / internals

Particularly in the case of in-the-ear hearing aids, there is the problem that the application area, i.e. the ear canal, its shape changes. Obviously, this is the case with adolescents. But also in adults, the ear canal changes partially, mostly in a narrowing sense (e.g. so-called diver's ear).

In the case of in-the-ear hearing aids, this conventionally gives rise to the problem that even if the hearing aid installations themselves could be maintained over long periods of life, for example only the transmission behavior of the hearing aid would have to be adjusted according to the respective listening conditions, new hearing aids are nevertheless always being designed due to the fact that the previous ones no longer fit the ear canal satisfactorily.

The measures explained in section 3 already provide the opportunity to improve this, due to the fact that this enables the otoplastic to be automatically adapted to the changing application areas. In this section, further measures are to be explained in this regard, in particular on the basis of in-ear earmolds. However, it should be pointed out that even with outer ear earmolds, such as outer ear hearing aids, this opens up the possibility of changing the “housing”, and not only if this is the case is necessary in terms of wearing comfort, but also, if desired, for example to change the aesthetic appearance of such external ear hearing aids.

In FIG. 22, an in-ear earmold 65 is shown schematically and in longitudinal section, in which the shape of the inner space 67 essentially corresponds to the shape of the electronics module 69 to be accommodated, which is shown schematically in FIG. 23. The otoplastic 65 is made of rubber-elastic material and, as shown in FIG. 23, can be put over the electronics module 69. The formation of the

Interior 67 is such that the one or more modules to be accommodated are positively positioned and held directly by the otoplastic 65. Because of this procedure, it is easily possible to use one and the same electronic module 69 with different ones

To provide earmoulds 65, for example in the case of a growing child of the changing

Ear canal training. The earmold practically becomes an easily replaceable disposable accessory for the in-the-ear hearing aid. The earmold 65 can be easily replaced not only to take account of changing conditions in the application area, namely the auditory canal, but also simply for reasons of contamination. This concept can even be used for this, if necessary - for example at

Ear canal infections - medical applications, for example by applying medication to the outer surface of the earmold or at least in order to use sterilized earmolds at regular intervals. The concept shown in FIGS. 22 and 23 can of course be combined with the concepts set out in sections 2) and 3), and the otoplastic 65 is preferably produced according to the manufacturing process explained in section 1), which involves the formation of the most complex internal shapes - And vibration-free recording of the module 69 enables.

As can be seen from FIGS. 22 and 23, the phase plate 1, which is otherwise provided in conventional in-the-ear hearing aids, is built integrally with the otoplastic, for example as part of the module holder. The same applies to further holders and receptacles for electronic components of the hearing aid. If the layer-by-layer build-up method described in section 1) is implemented, as shown by dash-dotted lines in FIG. 22 and in the direction indicated by the arrow AB, then it should be possible without further ado, the otoplastic in the mentioned direction AB according to requirements to be made from different materials in the respective areas. This also applies to the earmoulds set out in sections 2) and 3) and to those explained in the following sections 5), 6) and 7). Using the example of FIG. 22, it is therefore entirely possible to manufacture the area 65 _a from rubber-elastic material, whereas the exit area 65 _{b is} made from more dimensionally stable material.

24 is another embodiment of one

Otoplasty, again as an example using an in-the-ear hearing aid, is shown, which enables the internal fittings to be replaced quickly and easily. Basically, it is proposed to multiply the otoplastic shell on an in-ear otoplastic with internals to be assembled, as shown in FIG. 24. By means of fast-acting closures, such as snap-in closures, latch-in closures or even bayonet-like closures, it is possible to quickly separate housing parts 73a and 73b on the in-ear earmold, to remove the internals such as electronic modules and to re-install them in a new shell, if necessary with a changed outer shape or basically in a new bowl, even if this is necessary for cleaning reasons, sterility reasons, etc. If it is intended to throw away the already used shell, it is readily possible to design the connections of the shell parts in such a way that the shell can only be opened in a destructive manner, for example by providing locking elements such as latches that are not accessible from the outside and cutting the shell open for their removal becomes.

This embodiment can of course also be combined with the embodiment variants described so far and still to be described.

5. Integration of acoustic conductors in earmolds or their shells

In the case of outer ear as well as in-the-ear hearing aids, it is customary to couple provided acoustic / electrical transducers or electro-acoustic output transducers to the surroundings of the hearing aid on the input or output side via acoustic conductors assembled as independent parts, namely tube-like structures. or, in particular with acoustic / electrical transducers on the input side, these with their receiving surface directly in the To place areas of the surfaces of the hearing aid, possibly separated from the environment only by slight cavities and protective measures.

In the design of such hearing aids, there is a relatively large bond between where the actual transducers are to be found in the hearing aid and where the actual coupling openings to the surroundings are to be provided on the hearing aid. It would be highly desirable to have the greatest possible freedom of design with regard to the arrangement of coupling openings to the surroundings and the arrangement of the transducers mentioned within the hearing aid.

This is basically achieved by integrating the above-mentioned acoustic conductors - on the input side of acoustic / electrical transducers or on the output side of electrical / acoustic transducers - into the otoplastic and into the wall of otoplastic shells.

This is shown purely schematically in FIG. 25. A converter module 75 has an acoustic input or output 77. The shell 79 of the otoplastic of an in-the-ear or an outer-ear hearing device or a headphone has, integrated in it, an acoustic conductor 81. It lies at least in sections and, as shown in FIG. 25, within the wall of the otoplastic shell 79. The respective acoustic impedance of the acoustic conductor 81 is preferably adapted by means of acoustic stub lines or line sections 83. This concept, with a view to outer ear hearing aids, makes it possible to provide acoustic input openings 85 offset along the hearing aid and, if desired, via acoustic openings integrated in the otoplastic or its shell 87 To couple conductors 89 to the provided acoustic / electrical transducers 91, essentially regardless of where these transducers 91 are installed in the hearing aid. 26 only shows, for example, centralizing two transducers into one module and connecting their inputs to the desired receiving openings 85 by the aforementioned guidance of the acoustic conductors 89. From consideration of FIGS. 25 and 26 and the explanations in section 2) with regard to the novel ventilation systems, it becomes clear that it is quite possible to use ventilation channels as acoustic conductor channels, especially if, as schematized in FIG. 25, by means of acoustic adapter elements 83 the acoustic impedance conditions are specifically designed.

6. Labeling of earmolds

In the manufacture of earmolds, in particular in-ear earmolds, each is individually adapted to its respective wearer. Therefore, it would be extremely desirable to mark each manufactured earmold, as mentioned in particular each in-the-ear earmold, and particularly each in-the-ear hearing aid. It is therefore proposed to provide an individual marking in the otoplastic or in its shell, by indentations and / or by bulges, which in addition to the individual customer - e.g. Manufacturer -

Product serial number, left-right application etc. may contain. Such a marking is created in a much preferred manner during the manufacture of the earmold using the removal method described under 1). This ensures that there is no confusion from production the earmold is excluded. This is particularly important in the subsequent, possibly automated assembly with further modules, for example the assembly of in-the-ear hearing aids.

This procedure can of course be implemented in combination with one or more of the aspects described in sections 2) to 5).

7. Optimization of earmolds with regard to the dynamics of the application area

For the shaping of earmolds for in-the-ear

Application, for example for in-the-ear hearing aids, it is common today to take an impression of the auditory canal, for example in silicone. If one now takes into account the relatively large movement dynamics of the ear canal, for example during the chewing process, it can be seen that the support of the in-ear earmold form on an impression which practically corresponds to a snapshot hardly leads to a result which is completely satisfactory in use. As is now shown in FIG. 27 with the aid of a simplified function block / signal flow diagram, the dynamic application area, represented by block 93, takes shape at several positions corresponding to the dynamics occurring in practice or, like a film, the dynamics of the application area itself registered . The resulting records are in a

Storage unit 95 filed. Even with the conventional procedure of taking impressions, this can certainly be achieved by taking the impressions corresponding to the practical dynamics from the application area in two or more positions. These impressions are then scanned and the respective digital data records are stored in the storage unit 95. As a further possibility, the dynamics of the application area can, for example, be recorded by means of X-ray images.

Depending on the accuracy to be achieved, several “images” or even practically a “film” of the movement pattern of the application area of interest are registered. The data registered in the storage unit 95 are then fed to a computing unit 97. On the output side, the computing unit 97 controls the manufacturing process 99 for the earmold. If, for example, and as is still the case today, in-ear earmoulds are manufactured with a relatively hard shell, the computing unit 97 calculates the best fit for the dynamic data stored on the storage unit 95 and, if necessary, as shown schematically at K, other manufacturing parameters the earmold, so that optimal comfort is achieved in everyday life, while maintaining its functionality. If the otoplastic to be manufactured is implemented according to the principle set out in section 3), the computing unit 97 determines which otoplastic areas are to be designed and how, in terms of their flexibility, bendability, compressibility, etc., as mentioned, the computing unit 97 controls the manufacturing process 99 , preferably the

Manufacturing process, as set out in Section 1) as the preferred process.

Claims

Patent claims:

1. A method for producing earmolds for an application area that is moved dynamically and individually, characterized in that a three-dimensional image of the application area on at least two

Positions of its movement is registered and with this registration the design of the earmold is optimized with regard to the moving application area.

2. The method according to claim 1, characterized in that an image of the

Application area is registered.

3. The method according to any one of claims 1 or 2, characterized in that the resting outer shape of the otoplastic is optimized with the registrations.

4. The method according to any one of claims 1 to 3, characterized in that the shape behavior of the otoplastic is optimized with the registrations.

5. The method according to any one of claims 1 to 4, characterized in that the design is carried out by means of computational optimization and the production of the earmold is controlled with the design which is found to be optimal and is computationally determined.

6. Use of the manufacturing method according to one of claims 1 to 5 for in-ear earmolds, in particular for in-ear hearing aids.