`US 20040107080Al
`
`(19) United States
`(12) Patent Application Publication
`Deichmann et al.
`
`(10) Pub. No.: US 2004/0107080 Al
`Jun. 3, 2004
`(43) Pub. Date:
`
`(54) METHOD FOR MODELLING CUSTOMISED
`EARPIECES
`
`(76)
`
`Inventors: Nikolaj Deichmann, Copenhagen
`(DK); Tais Clausen, Copenhagen (DK);
`Rune Fisker, Copenhagen (DE);
`Christophe Vasiljev Barthe,
`Copenhagen (DK)
`
`Correspondence Address:
`JACOBSON HOLMAN PLLC
`400 SEVENTH STREET N.W.
`SUITE 600
`WASHINGTON, DC 20004 (US)
`
`(21) Appl. No.:
`
`10/469,591
`
`(22) PCT Filed:
`
`Mar. 1, 2002
`
`(86) PCT No.:
`
`PCT/DK02/00137
`
`(30)
`
`Foreign Application Priority Data
`
`Mar. 2, 2001
`Mar. 28, 2001
`Oct. 17, 2001
`
`(DK) ................................ PA 2001 00346
`(DK) ................................ PA 2001 00519
`(DK) ................................ PA 2001 01521
`
`Publication Classification
`
`Int. Cl.7 ....................................................... G06G 7/48
`(51)
`(52) U.S. Cl. .................................................................. 703/6
`
`(57)
`
`ABSTRACT
`
`The present invention relates to a method for computer(cid:173)
`controlled modelling of customised earpieces. These ear(cid:173)
`pieces include housings for hearing aids, wireless or con(cid:173)
`nected communication devices (headsets, mobile phones,
`personal agents), loud speakers, tinnitus masking devices,
`devices recording vibrations in the skull and transforming
`these into audio signals, voice recognition devices, earplugs,
`noise blockers with selective frequencies or sound levels,
`Man Machine Interface (MMI) products that enable clear
`communication even in the noisiest environments, or prod(cid:173)
`ucts related to wireless Internet applications. All these
`earpieces may be worn in the user's meatus and/or auditory
`canal. The invention also relates to a computerised system
`for manufacturing such customised earpieces. In particular,
`the invention is directed to a computerised system that
`models an earpiece based on a three-dimensional replica of
`the user's meatus and/or auditory canal.
`
`103
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`104
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`102
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`106
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`109
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`101
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`108
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`3SHAPE 1014 3Shape v Align IPR2021-01383
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`Patent Application Publication
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`Jun. 3, 2004 Sheet 1 of 41
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`US 2004/0107080 Al
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`
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`Figure |
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`Patent Application Publication
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`Jun. 3, 2004 Sheet 2 of 41
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`US 2004/0107080 Al
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`103
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`108
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`Figure 2
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`Patent Application Publication
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`Jun. 3, 2004 Sheet 3 of 41
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`US 2004/0107080 Al
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`107
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`Figure 3
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`Patent Application Publication
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`Jun. 3, 2004 Sheet 5 of 41
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`US 2004/0107080 Al
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`base
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`Patent Application Publication
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`Jun. 3, 2004 Sheet 6 of 41
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`US 2004/0107080 Al
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`Patent Application Publication
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`Jun. 3, 2004 Sheet 7 of 41
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`US 2004/0107080 A1
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`Patent Application Publication
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`Jun. 3, 2004 Sheet 8 of 41
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`Patent Application Publication
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`Jun. 3, 2004 Sheet 9 of 41
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`US 2004/0107080 Al
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`Patent Application Publication
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`Jun. 3, 2004 Sheet 10 of 41.
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`US 2004/0107080 Al
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`
`Removal defects
`
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`
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`
`Initial cutting /
`Creation virtual ear
`
`Cutting canal/
`Filleting
`
`Components
`placement
`
`Adding material
`
`Cutting visible
`surface
`
`
`
`
`Final placement
`
`Creation of
`faceplate / locks
`
`Lofting
`
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`ventilation channel
`
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`
`Difference map
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`
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`Patent Application Publication
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`Jun. 3, 2004 Sheet 11 of 41
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`US 2004/0107080 Al
`1101
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`Figure 11
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`Patent Application Publication
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`Jun. 3, 2004 Sheet 12 of 41.
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`US 2004/0107080 Al
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`Figure 12
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`Patent Application Publication
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`Jun. 3, 2004 Sheet 13 of 41.
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`US 2004/0107080 Al
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`1304
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`Patent Application Publication
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`Jun. 3, 2004 Sheet 14 of 41.
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`US 2004/0107080 Al
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`1404
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`Patent Application Publication
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`Jun. 3, 2004 Sheet 15 of 41.
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`US 2004/0107080 Al
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`1502
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`3SHAPE 1014
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`Jun. 3, 2004 Sheet 16 of 41.
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`US 2004/0107080 Al
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`Patent Application Publication
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`1603
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`1601
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`Patent Application Publication
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`Jun. 3, 2004 Sheet 17 of 41.
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`US 2004/0107080 Al
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`Jun. 3, 2004 Sheet 18 of 41.
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`US 2004/0107080 Al
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`Jun. 3, 2004 Sheet 19 of 41.
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`US 2004/0107080 Al
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`Patent Application Publication
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`1903
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`Jun. 3, 2004 Sheet 20 of 41.
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`Jun. 3, 2004 Sheet 21 of 41.
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`Jun. 3, 2004 Sheet 22 of 41.
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`US 2004/0107080 Al
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`Jun. 3, 2004 Sheet 23 of 41.
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`Jun. 3, 2004 Sheet 24 of 41.
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`US 2004/0107080 Al
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`Jun. 3, 2004 Sheet 25 of 41.
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`US 2004/0107080 Al
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`Jun. 3, 2004 Sheet 26 of 41
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`Jun. 3, 2004 Sheet 27 of 41.
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`Jun. 3, 2004 Sheet 28 of 41.
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`Jun. 3, 2004 Sheet 29 of 41.
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`US 2004/0107080 Al
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`Jun. 3, 2004 Sheet 30 of 41.
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`Jun. 3, 2004 Sheet 31 of 41.
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`Jun. 3, 2004 Sheet 34 of 41.
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`Jun. 3, 2004 Sheet 39 of 41.
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`Jun. 3, 2004 Sheet 41 of 41.
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`US 2004/0107080 Al
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`US 2004/0107080 Al
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`Jun.3,2004
`
`1
`
`METHOD FOR MODELLING CUSTOMISED
`EARPIECES
`
`[0001] This application is a non-provisional of U.S. pro(cid:173)
`visional application Serial No. 60/275,112 flied 13 Mar.
`2001, which is hereby incorporated by reference in its
`entirety. It claims priority from Danish patent applications
`no PA2001 00346 filed on 2 Mar. 2001, PA200100519 filed
`on 28. March 2001 and PA200101521 filed on 17 Oct. 2001,
`which are hereby incorporated by reference in their entirety.
`
`[0002] All patent and non-patent references cited in the
`application, or in the present application, are also hereby
`incorporated by reference in their entirety.
`
`TECHNICAL FIELD OF THE INVENTION
`
`[0003] The present invention relates to a method for
`computer-controlled modelling of customised earpieces.
`These earpieces include housings for hearing aids, wireless
`or connected communication devices (headsets, mobile
`phones, personal agents), loud speakers, tinnitus masking
`devices, devices recording vibrations in the skull and trans(cid:173)
`forming these into audio signals, voice recognition devices,
`earplugs, noise blockers with selective frequencies or sound
`levels, Man Machine Interface (MMI) products that enable
`clear communication even in the noisiest environments, or
`products related to wireless Internet applications. All these
`earpieces may be worn in the user's meatus and/or auditory
`canal. The invention also relates to a computerised system
`for manufacturing such customised earpieces. In particular,
`the invention is directed to a computerised system that
`models an earpiece based on a three-dimensional replica of
`the user's meatus and/or auditory canal. The system also
`provides for a number of operations and modifications to be
`performed on the reproduction.
`
`BACKGROUND OF THE INVENTION
`
`[0004] Many existing applications, such as in-the-ear
`(ITE), in-the-channel (ITC), or completely-in-the-channel
`(CIC) housings for hearing aids and personal communica(cid:173)
`tion devices (mobile phones or headsets) require the repro(cid:173)
`duction of one-of-a-kind parts of complex geometry. In these
`applications, the parts are unique and require a highly
`precise fit of the replacement part Sub-millimetre precision
`is for example required for ITE, ITC or CIC hearing aid
`housings; the housing Will otherwise cause inconvenience
`feedback, as well as irritation and possibly infection to the
`epidermis of the ear canal.
`
`[0005] Existing methods to model and manufacture cust(cid:173)
`omised housings for hearing aids are very long and tedious
`processes. They introduce a great deal of uncertainty about
`the quality of the finished product. The process typically
`implies the creation of an impression of the user's ear canal.
`This impression must be adjusted manually and a mould
`replicating the user's meatus is created from the impression,
`either in plaster, gel, or silicone resin. A polymerisable liquid
`synthetic resin is produced, poured into the mould and
`polymerised at least partially. If the desired product is a shell
`for an individually fitted hearing aid housing, most of the
`liquid synthetic resin must be poured out of the mould again,
`before it completely polymerises. The resulting shell is
`ground to the desired size and appearance. The components
`must then be fitted manually into the shell; this operation is
`
`often problem-prone, since the shell has been designed
`without taking proper account of the components' shape and
`size.
`
`PRIOR ART
`
`[0006] U.S. Pat. No. 5,121,333, U.S. Pat. No. 5,121,334,
`U.S. Pat. No. 5,128,870. U.S. Pat. No. 5,184,306, U.S. Pat.
`No. 5,027,281, and U.S. Pat. No. 5,257,203 (REGENTS OF
`THE UNIVERSITY OF MINNESOTA) describe a method
`and apparatus for the automated reproduction of three(cid:173)
`dimensional objects of complex and unique geometry. A
`computer acquires data describing an object and its sur(cid:173)
`roundings, constructs a computer-based three dimensional
`model of the object from the data, superimposes an ideal
`geometry on the computer-based model, alters the ideal
`geometry to fit the form and function required of the
`reproduction, and then guides a milling machine in the
`fabrication of the reproduction.
`
`[0007] WO 00/34739 (FAGAN ET AL.) concerns a
`method for manufacturing hearing aid shells involving the
`use of a specially adapted ultrasonic probe head to safely
`measure the contours of the ear canal without contact with
`the surface being measured. The recording of data in the ear
`canal is made possible by filling the canal with a liquid and
`inserting the ultrasonic probe The scan data is processed by
`a computer and the data is used with a rapid prototyping
`set-up such as stereo lithography, selective laser sintering,
`laminate object modelling, inkjet modelling, fused deposit(cid:173)
`ing modelling, 3D or any other system that produces real
`models from computer mathematical models to manufacture
`the hearing aid shell. EP O 516 808 (T0PHOLM & WES(cid:173)
`TERMANN APS) concerns a method for computer-assisted
`manufacture of otoplastics individually fitted to the contours
`of the ear canal. According to the described method a digital
`representation of the internal contours of the ear canal is
`used for the production of a hearing aid shell, and the digital
`representation Is used to obtain a computer model, which
`can be used for manual location of the components of the
`hearing aid and for defining the thickness of the shell's
`walls.
`
`[0008] U.S. Pat. No. 5,056,204 (ASCOM AUDIOSYS
`AG) concerns a method for the milling of hearing aids
`whereby the internal contours of the ear canal are recorded
`by a laser apparatus located outside the ear of the user.
`
`[0009]
`JP09103000A2 (RION CO LTD) describes a
`method for the production of shell for ear-inserted hearing
`aids whereby a three-dimensional shape measuring instru(cid:173)
`ment is used to measure the shape information of the
`external auditory meatus directly or using a an ear model
`sampled by using a sealing member. Next, the shape infor(cid:173)
`mation and information on the shape of the components to
`be integrated into a shell for hearing aid are inputted to a
`computer, and an external shape or an internal shape of the
`hearing aid shell is decided. Afterwards, the three-dimen(cid:173)
`sional shape data of the external or internal shape decided by
`the computer system are inputted to an optical moulding
`device and the hearing aid shell is directly produced by an
`optical moulding method.
`
`[0010] WO 01/05207 (PHONAKAG) discloses a method
`for production of otoplastics, whereby an impression of the
`shape of the individual auditory canal is taken in order to
`produce shells for hearing aids implanted in the ear that very
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`precisely adapt to the individual shape of the auditory canal
`and a hearing aid shell is produced by means of an additive
`fabrication process such as laser sintering, stereolithography
`or a thermojet process that is controlled by means of data
`pertaining to the shape. The disclosure provides no infor(cid:173)
`mation on how to model the otoplastics including the
`placement of components.
`
`[0011]
`Just placing components (as mentioned in EP O 516
`808, T0PHOLM & WESTERMANN APS) or just cutting
`away parts of the original 3D model only give weak indi(cid:173)
`cations of the full earpiece and the result is likely to be of
`low quality. Furthermore, these prior art methods do not
`disclose how to model complex earpieces with more fea(cid:173)
`tures.
`
`[0012] While concepts for the computer-assisted model(cid:173)
`ling and subsequent direct manufacturing of custom-fitted
`earpieces, especially hearing aid housings, are mentioned in
`the prior art, none of the above-cited references directly
`discloses steps or operations, which may be involved in the
`modelling process of such customised earpieces. Thus, there
`is a need for a method and/or providing one or more such
`steps or operations that can be used in order to optimise the
`modelling and production of customised earpieces. Such a
`method and/or system is provided according to the present
`invention.
`
`SUMMARY OF THE INVENTION
`
`[0013] FIG. 5 shows an overview of how the tedious
`manual process can be computer-assisted or computer-con(cid:173)
`trolled leading to faster production, lower cost and higher
`acoustic and physical quality. The process consists of three
`main steps: 3D scanning of the impression/ear, virtual 3D
`modelling of the earpiece and finally manufacturing. The
`invention primarily relates to 3D modelling of the original
`3D model acquired by the scanner as illustrated in FIG. 10.
`
`[0014] The invention enables the virtual creation of a
`complete earpiece by arranging relevant components in
`relation to the 3D model using collision control, cutting
`away the unwanted parts of the 3D model and forming a
`surface, which connects components and the 3D model. The
`creation of the full earpiece facilitates a true evaluation of
`the properties of the final earpiece, e.g. visual and acoustic
`properties and room for components taking into account the
`constraint by all surfaces. Additionally the virtual creation of
`the full earpieces enables the physical manufacturing of the
`full earpieces eliminating a large number of costly manual
`post processing operations.
`
`[0015] According to a first aspect of the present invention
`there is provided a method for computer-assisted modelling
`of customised earpieces comprising at least one part being
`individually matched to an auditory canal and/or a meatus,
`said method comprising the steps of:
`
`[0016]
`three-dimensional computer
`a) obtaining a
`model, 3D-model, of at least part of the auditory canal,
`said 3D-model having an outer surface,
`
`[0017] b) initially arranging at least one component in
`relation to the 3>D-model,
`
`[0018] c) initially arranging a cutting curve or cutting
`surface in relation to the outer surface of the 3D-model,
`
`said cutting curve or surface dividing the 3D-model in
`an outer portion and an inner portion,
`[0019] d) initially forming a connecting surface con(cid:173)
`necting the at least one component and the inner
`portion of the 3D-model, said connecting surface
`thereby being part of the 3D-model,
`[0020] e) performing an evaluation of the arrangement
`of the at least one component, said evaluation com(cid:173)
`prising a collision detection of the at least one compo(cid:173)
`nent in relation to one or more parts of the 3D-model
`and/or other components, and
`[0021]
`t) adjusting the arrangement of the at least one
`component, the arrangement of the cutting curve or
`surface, and/or the formation of the connecting sur(cid:173)
`face based on the result of said evaluation.
`
`[0022] An initial cut to divide the 3D model in an inner
`and outer portion is not mentioned anywhere in the prior art
`relating to computer-assisted 3D modelling of customised
`earpieces. Such an initial cut is used in the manual modelling
`of earpieces based on impressions. In contrast to the manual
`method one primary advantage of the method according to
`the invention is that the initial cut performed on the
`3D-model is optimisable, since it can be changed during the
`adjustment step based on the evaluation step. This is not
`possible when modelling earpieces manually and the possi(cid:173)
`bility of optimising the initial cut in computer-assisted
`modelling of customised earpieces is mentioned nowhere in
`the prior art The fact that the initial cut can be optimised
`makes the method more flexible than the methods of the
`prior art.
`[0023] According to the methods of the prior art, there is
`no guarantee that the components actually fit into the
`earpiece. In contrast to this the present invention physically
`places the components in the earpiece (in a modelling
`operation) to make sure that there is space for the compo(cid:173)
`nents. According to the present invention, if there is too little
`room for the components, further rounds of optimisation can
`be performed, the optimisation process can be repeated,
`material can be removed from the shell or the initial cutting
`curve/surface can be moved to create more space. The initial
`cut, dividing the 3D-model in an inner and outer portion also
`makes it possible to make a visualisation of the modelled
`earpiece in a virtual ear. Such visualisation and optimisation
`for appearance is not described in the prior art. The visual
`appearance of an earpiece is very important for the wearer.
`Furthermore according to the present invention, there is
`provided a method for modelling the complete 3D earpiece
`with all its surfaces. The methods disclosed in the prior art
`fail to provide a disclosure of how to arrange a connecting
`surface connecting the 3D model with the at least compo(cid:173)
`nent and thereby fail to teach a method for modelling the
`complete earpiece. The fact that the complete modelling of
`a 3D-earpiece is rendered possible by the instant invention,
`also makes it possible to make an optimisation of the
`acoustic properties of the earpiece in the computer prior to
`prototyping and assembling it. The fact that the complete
`earpiece can be modelled also makes it possible to prototype
`the whole piece in one operation thus obviating the need for
`assembling the piece from several pieces, such as an ear(cid:173)
`piece and a faceplate. However, it is still possible to incor(cid:173)
`porate a faceplate into the modelling according to the
`invention if so desired.
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`[0024] All 3D models irrespective of whether they are
`obtained by scanning an impression or by direct scanning of
`the auditory canal and/or meatus need to have at least the
`outer boundary of the piece modelled in order to obtain a
`complete earpiece.
`
`[0025] Furthermore, the possibility of optimising the
`placement of the at least one component and the connecting
`surface gives the possibility of optimising the visual appear(cid:173)
`ance of the piece in the arm.
`
`[0026]
`In addition, an important advantage of the present
`invention is that the earpiece is only manufactured (through
`rapid prototyping) once it has been established that all the
`components of the earpiece are located in the optimum
`location.
`
`[0027] The order of the steps of the method according to
`the invention can be any.
`
`[0028] Examples of preferred orders include, but are not
`limited to a) b) c) d) e) f); a) c) b) d) e) l); a) c) b) e) d) f);
`a) b) e) c? d) f): a) b) c) e) d) f). A preferred order is a) b)
`c) d) e) f), because it has turned out that by arranging the at
`least one component first, and arranging the cutting curve/
`surface with the aid of the at least one component makes it
`possible to model an optimal connecting surface in fewer
`steps and often to reach the optimal or at least an acceptable
`placement of the connecting surface in just one round.
`
`[0029] The adjustment process may include either the
`arrangement of the at least one component, the arrangement
`of the cutting curve or surface, or the formation of the
`connecting surface or it may include any combinations of
`the arrangement of the at least one component, the arrange(cid:173)
`ment of the cutting curve or surface, and/or the formation of
`the connecting surface. It is preferred that when the arrange(cid:173)
`ment of the at least one component and/or the arrangement
`of the cutting curve or surface has/have been adjusted, the
`formation of the connecting surface is adjusted.
`
`[0030] According to an embodiment of the invention, the
`arrangement of the at least one component in relation to the
`3D-model may comprise arranging the at least one compo(cid:173)
`nent in relation to a component surface, and arranging said
`component surface in relation to the 3D-model. Here, the
`connecting surface may be connecting said component sur(cid:173)
`face and said inner portion of the 3D-model, It is preferred
`that the collision detection includes a collision detection of
`the component surface in relation to one or more parts of the
`3D-model.
`
`[0031] The collision detection may further include a col(cid:173)
`lision detection of the mutual arrangement of the compo(cid:173)
`nents themselves.
`
`[0032] When arranging the components, it is preferred that
`the initial arrangement of the at least one component in
`relation to the 3D-model comprises arranging at least part of
`the components substantially at the interior of the 3D-model.
`
`[0033]
`It should be understood that it is also within the
`present invention to have the evaluation process including
`an evaluation of the arrangement of the cutting curve or
`surface and/or the connecting surface.
`
`[0034]
`It is preferred that the formation of the connecting
`surface is computer controlled or computer assisted. It is
`also preferred that the formation of the connecting surface
`
`comprises a lofting process, where the lofting process may
`comprise fitting a parametric surface to the boundary of the
`inner portion of the 3D-model and to the boundary of a
`surface defining an outer boundary of the arrangement of
`said at least one component in relation to the 3D-model.
`Here, the outer boundary of the arrangement of said at least
`one component in relation to the 3D-model may be defined
`by the outer boundary of the component surface.
`
`[0035]
`It is also within an embodiment of the invention
`that the formation of the connecting surface comprises a
`filleting process of the edge or boundary of the inner portion
`of the 3D-model. Here, the outer shell surface of the
`3D-model may be given in a vertex representation with the
`vertices being connected by triangles, and the filleting
`process may comprise removing at least part of the triangles
`in a neighbourhood around at least part of said edge and
`fitting a parametric surface to the neighbourhood of the hole
`created by the removed triangles.
`
`[0036] According to an embodiment of the invention, at
`least part of the inner portion of the 3D-model is shelled.
`Here, the shelling process may be part of a modelling
`process according to the present invention, and the shelled
`inner portion may have an inner and an outer shell surface.
`
`[0037] According to a preferred embodiment of the inven(cid:173)
`tion, the inner portion of the 3D-model at least partly
`comprises a representation of a model of an earpiece.
`
`[0038]
`In another embodiment of the invention the outer
`portion of the 3D-model at least partly comprises a model of
`a virtual ear.
`
`[0039]
`It should be understood that it is preferred that said
`one or more parts of the 3D model in relation to which the
`collision detection may be performed comprise at least part
`of the inner portion and/or at least part of the outer portion
`of the 3D-model. Here, said one or more parts of the
`3D-model in relation to which the collision detection may be
`performed may comprise at least part of the inner shell
`surface and/or at least part of an inner surface of the virtual
`ear.
`
`[0040] According to a preferred embodiment of the inven(cid:173)
`tion the collision detection and the adjustment, process may
`be repeated until the collision detection fulfils a required
`minimum criterion.
`
`[0041]
`It should be understood that the initial arrangement
`of the at least one component and/or the cutting curve or
`surface may be performed in several ways in accordance
`with the present invention. Thus, the initial arrangement
`may be performed manually or be computer-controlled or
`computer-assisted. The initial arrangement may be per(cid:173)
`formed using a feature-based approach, in which features
`extracted from the obtained 3D-model are used for the
`arrangement, or performed using a similarity-based
`approach, in which the obtained 3D-model is compared to a
`number of stored 3D-models of previously generated opti(cid:173)
`mised models.
`
`[0042] When using a similarity-based approach a stored
`optimised 3D-model may be selected as the most similar
`3D-model and the initial arrangement of the at least one
`component and/or the cutting curve or surface may be
`selected substantially equal to the optimised arrangement of
`the at least one component and/or cutting curve or surface of
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`said most similar 3D-model. Here, the comparison of
`3D-models and selection of the most similar 3D-model may
`be computer-controlled or computer-assisted.
`
`[0043]
`It should also be understood that according to the
`present invention, the adjustment of the arrangement of the
`at least one component and/or the cutting curve or surface