s
`
`United States Patent
`Sheehan et al.
`
`[19]
`
`[54] DISPOSABLE ELEMENT FOR USE WITH A
`HEARING SCREENER
`
`[75]
`
`Inventors: Neil J. Sheehan, Palo Alto; Robert T.
`Stone, Sunnyvale, both of Calif.
`
`[73] Assignee: Natus Medical Inc., San Carlos, Calif.
`
`[21] Appl. No.: 08/861,725
`
`[22]
`
`Filed:
`
`May 22, 1997
`
`Int. C1.6
`[51]
`[52] U.S. Cl.
`[58] Field of Search
`
`A61F 5/37
`128/846; 128/864; 2/209
`128/846, 864 -868;
`2/209, 423, 455; 181/129
`
`[56]
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`2,570,675 10/1951 Heflin
`7/1954 Lienard
`2,684,067
`8/1957 Hanks
`2,802,214
`1/1964 Carrell et al.
`3,117,575
`3,841,325 10/1974 Pickard
`4/1975 Aileo
`3,875,592
`2/1976 Ahs
`3,938,614
`3/1976 Satory
`3,944,018
`3/1977 Ward
`4,009,707
`5/1977 Bosscher
`4,024,499
`7/1977 Hathaway
`4,036,235
`1/1979 Voorhees
`4,134,153
`1/1982 Voorhees
`4,308,623
`8/1982 Strauss
`4,344,425
`
`128 /151
`128/152
`2/209
`128/152
`128 /151
`2/209
`181/129
`181/33
`128/2
`340/16.2
`128/292
`2/174
`2 /174
`128/152
`
`i11111nis111mo11!h111111111NUUt
`
`[11] Patent Number:
`[45] Date of Patent:
`
`5,913,309
`Jun. 22,1999
`
`4,375,744
`4,408,605
`4,437,538
`4,616,643
`4,930,520
`5,243,709
`
`3/1983 Briner et al.
`57/96
`10/1983 Doerr ....... ............................... 128/402
`3/1984 Ohlsson
`181/129
`10/1986 Jung
`128 /151
`6/1990 Liverani
`128/746
`9/1993 Sheehan et al.
`2/209
`
`Primary Examiner - Michael A. Brown
`Attorney, Agent, or Firm Orrick, Herrington & Sutcliffe
`LLP
`
`[57]
`
`ABSTRACT
`
`A disposable element for ear phone assembly is provided for
`use with a hearing screening instrument to test infants for
`hearing impairments. The ear phone assembly includes a
`generally D- shaped reusable cover including a back wall
`having a perimeter, a side wall extending from the perimeter
`to define a cavity for receiving an infant's ear, a port in the
`cover to receive and support a transducer, and a generally
`D- shaped disposable element that is adhesive coated on two
`sides to be secured to the cover and to the patient's head. The
`cover may have a notch located along the perimeter of the
`re- usable body for removing the disposable element. A liner
`is used to cover the disposable element adhesive sides to
`protect them from contamination during packaging and prior
`to use. The disposable element may have a die cut so that a
`portion of it can be removed to make the ear phone adjust-
`able for infants with large ears. The ear phone is low in cost
`and capable of being used with any conventional hearing
`screening equipment.
`
`30 Claims, 3 Drawing Sheets
`
`38
`
`34
`
`37
`
`LINER
`38
`
`DISPOSABLE
`ELEMENT
`
`34
`
`32
`
`PORT
`30
`
`COVER
`10
`
`34
`
`37
`
`LINER
`8
`
`34
`
`31
`
`35
`
`E
`
`DEPOSITION
`EXHIBIT
`
`2..al7
`
`Ex. 2016-0001
`
`

`
`U.S. Patent
`
`Jun. 22,1999
`
`Sheet 1 of 3
`
`5,913,309
`
`DISPOSABLE
`ELEMENT
`
`OP`
`
`20
`
`34
`
`4
`
`7
`PORT
`30
`
`COVER
`1' 0
`
`FIG. 1
`
`Ex. 2016-0002
`
`

`
`U.S. Patent
`
`Jun. 22, 1999
`
`Sheet 2 of 3
`
`5,913,309
`
`FIG. 2
`
`13
`
`37
`
`37
`
`37
`
`44
`
`51\ .,.:/36
`
`55
`53
`
`40
`FIG. lo
`
`51\
`
`53
`
`FIG. 12
`
`Ex. 2016-0003
`
`

`
`U.S. Patent
`
`Jun. 22, 1999
`
`Sheet 3 of 3
`
`5,913,309
`
`35
`
`6 3
`
`2
`
`FIG. 3
`
`39
`
`_L.
`
`35
`
`29
`
`7
`
`FIG. 6
`
`FIG. 8
`
`19
`
`29
`
`13
`
`8
`
`35
`
`13
`
`35
`
`29
`FIG. 5
`
`29 19
`FIG. 7
`
`Ex. 2016-0004
`
`

`
`5,913,309
`
`1
`DISPOSABLE ELEMENT FOR USE WITH A
`HEARING SCREENER
`
`FIELD OF THE INVENTION
`The present invention generally relates to ear phones
`which cover the ear, and more particularly to ear phones for
`infants for use in hearing screening tests.
`
`BACKGROUND OF THE INVENTION
`
`It is known to conduct tests to identify hearing impair-
`ments in humans (also known as "hearing screening "). It is
`critical and advantageous to determine whether or not any
`hearing impairments exist at an early age, such as in
`newborns and infants. This is because the earlier a problem
`is diagnosed and therapy undertaken, the more likely the
`therapy or other intervention will minimize the potential
`problems and costs associated with the identified hearing
`impairments or loss.
`Over the years, hearing screening techniques have been
`developed which inject a sound input into the ear and detect
`a response to that input. The response is related to the
`characteristics of the sound input and the conditions inside
`the ear, the neural connections, and the vibration transmis-
`sion mechanism of the ear. The response can be analyzed to
`assess the hearing of the patient.
`In many cases, and in particular in the case of infants,
`hearing screening is performed by using an ear phone having
`a cavity that fits closely about the ear. Auditory tones or
`"clicks" are fed into the ear phone cavity, and the response
`generated by the patient's ear and the neural conduction
`system in response to the auditory tones is sensed by a
`transducer. The transducer may be, for example, a
`microphone, suitable electrodes, piezo electric materials and
`like devices that generate signals representative of the
`response to the auditory input. These signals are then
`processed and the result (as well as the detected signals, if
`desired) can be displayed on a monitor or other viewing
`device for analysis of the patient's hearing.
`A common problem using this method is that ambient
`noises, internal or external to the cavity, are capable of
`interfering with the stimulus or the response signals, and,
`thus, the result. In most cases, the monitoring equipment has
`mechanisms, such as microphones, for detecting and com-
`pensating for ambient background noise. However, compen-
`sating for noise inside the cavity is difficult.
`U.S. Pat. No. 4,930,520 to Liverani provides a disposable
`ear phone for testing the hearing in infants which includes a
`toroidal baffle of anechoic, insulative foam, a clear planar
`window plastic sheet adhered to one side of the baffle
`defining a cavity, and an adhesive coating on the other side
`of the baffle for bonding the disposable ear phone to the
`region surrounding the infant's ear. The ear phone is capable
`of being used with transducers for transferring acoustical
`energy through a pneumatic tube to the infant's ear for
`testing. The Liverani device has been commercialized and is
`sold under the trademark EAR COUPLERS® disposable
`earphones by Natus Medical Incorporated, the assignee of
`this invention.
`One of the problems with the Liverani device is that the
`ear phone is somewhat cost -ineffective in that the entire ear
`phone is not re- usable and must be disposed of after each
`use, and one device is used per ear. In particular, the
`construction and use of the device requires, according to
`accepted general medical practices, that after use it be
`disposed of as medical waste. Another problem of the
`
`2
`Liverani ear phone is that its construction is not capable of
`adjustment for infants with different size ears. As a result, it
`is necessary to manufacture different size ear phones and
`maintain an inventory of the different sizes to obtain accept -
`able test performance for patients having different sized ears.
`Thus, there remains a need for an improved ear phone that
`overcomes the problems of the known device and, further,
`provides advances that improves the attenuation of ambient
`and external noise inside the cavity of the ear phone.
`
`5
`
`lo
`
`20
`
`OBJECTS AND SUMMARY OF THE
`INVENTION
`Accordingly, it is an object of the present invention to
`provide a disposable element for an ear phone, particularly
`for screening the hearing of infants, which ear phone which
`has an improved cost effectiveness hi that it comprises a
`durable, reusable cover and which disposable element is a
`low -cost, smaller disposable element that is easily attached
`to the durable part for use and easily removed therefrom
`after use.
`It is another object to provide a disposable element that is
`capable of being used with ears of different sizes.
`It is another object of the invention to provide a dispos-
`25 able element and an ear phone assembly that is generally
`free from external noise.
`It is yet another object of the invention to provide a
`disposable element that is interchangeable in that it can be
`used with either a left ear cover or a right ear cover for use
`30 with testing of the left ear or the right ear.
`Broadly, the present invention is directed to a disposable
`element for a durable ear phone assembly, which is useful
`for measuring auditory signals in infants. The disposable
`element has a thickness and an adhesive on each side of the
`35 thickness such that one side of the disposable element
`becomes adhered to the cover and the other side is pressed
`in contact with the patient's skin around the ear. Thus
`assembled, the ear phone assembly is secured to the patient's
`head about the ear, and forms a chamber which acoustically
`4o isolates the ear from the ambient environment.
`In a preferred embodiment, the cover includes a port
`throughlwhich a transducer is inserted to conduct hearing
`screening tests. This permits the use of a highly durable
`transducer, which may be more durable than the cover and
`needs only to be cleaned after use.
`After the hearing screening tests are completed, the ear
`phone assembly can be removed from the patient, the
`disposable element separated from the cover and disposed
`so of, the transducer removed from the port, and the reusable
`durable cover can be cleaned and /or sterilized for the next
`use.
`The disposable elements are pre -formed with a toroidal
`shape corresponding to the perimeter of the cover, and the
`55 adhesives are pre- coated on the disposable element sides
`and, prior to use, are protectively covered with removable
`liners.
`In a preferred embodiment, the cover comprises a cavity
`and a flange to which the disposable element is adhered. The
`6o cavity provides a generally flat surface which extends over
`the ear when the ear phone assembly is in place. The cover
`may, however, be contoured so as to conform generally to
`the shape of the patient's head about the ear. As is well
`known, the area around the ear is not flat. Rather, the area is
`65 curved in three dimensions. The cover and in particular, the
`flange, may thus be provided with a shape that conforms to
`such a surface. For example, the cover may be formed in a
`
`45
`
`Ex. 2016-0005
`
`

`
`5,913,309
`
`3
`manner that can be described as having a relatively flat body
`with a folded edge. More specifically, the cover is "bent"
`along a diagonal such that the bend is actually provided with
`a radius so the cover conforms well to the head. More
`preferably, left ear covers and right ear covers are separately s
`provided having the appropriate bends to obtain a better fit
`for the patient.
`The port, which receives the transducer, is preferably an
`integral part of the cover. Further, the port also may include
`a projecting structure for supporting or at least engaging a
`transducer in a non -rotating relationship.
`Further, as applicants have discovered, an improved cover
`is obtained by providing the cover, and the corresponding
`disposable element, with a generally D- shape, such that the
`straight side of the "D" is flat and corresponds generally to
`a vertical axis, and the curved portion of "D" is basically
`symmetrical about a horizontal axis midpoint between the
`ends of the vertical axis. In this embodiment, the cover is
`"bent" about a diagonal extending from a sharp corner of the
`D -shape to the catty- corner rounded corner of the "D ". This
`bent structure advantageously provides for using the smaller
`cavity size of the D- shape, as compared to the larger cavity
`size of the Liverani device which is generally symmetrical
`about its vertical axis, and a better fit against the patient's
`head. This facilitates a generally noise -free chamber closely
`fitting about the ear in an improved air tight relationship for
`hearing screening.
`
`10
`
`15
`
`20
`
`25
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`Further features of the invention, its nature, and various
`advantages will become more apparent from the accompa-
`nying drawings, and the following detailed description of
`the invention, in which like reference numerals refer to like
`elements, and in which:
`FIG. 1 is an exploded elevated perspective view of an ear
`phone assembly for a left ear in accordance with a preferred
`embodiment of the present invention;
`FIG. 2 is a bottom elevated perspective view of a right ear
`cover which can be seem to be a mirror image of the left ear
`cover of FIG. 1;
`FIG. 3 is a bottom plan view of the cover of FIG. 2;
`FIG. 4 is a top plan view of the cover of FIG. 2;
`FIG. 5 is a side view taken along line 5 -5 of FIG. 4.
`FIG. 6 is an end view taken along line 9 -9 of FIG. 4;
`FIG. 7 is a side view taken along line 7 -7 of FIG. 4;
`FIG. 8 is an end view taken along line 8-8 of FIG. 4;
`FIG. 9 is a plan view of a preferred embodiment of the
`disposable element of FIG. 1;
`FIG. 10 is a sectional view taken along lines 11 -11 of
`FIG. 10;
`FIG. 11 is a top view of the disposable element of FIG. 1
`in accordance with another embodiment of the present
`invention; and
`FIG. 12 is a sectional view taken along lines 13-13 of
`FIG. 11.
`
`30
`
`35
`
`4
`
`45
`
`50
`
`55
`
`DETAILED DESCRIPTION OF THE DRAWINGS
`Referring to FIG. 1, the left ear phone assembly 3 in
`accordance with the present invention comprises a cover 10
`and a disposable element 20. The cover 10 is a durable,
`reusable element that includes a cavity 50 to cover the ear
`without interfering with the normal shape of the ear. The 65
`disposable element 20 is a generally planar element that is
`to be mounted to the cover 10 on one side and to the patient's
`
`60
`
`4
`head on the other side. The disposable element 20 thus
`effectively increases the depth of cavity 50 which covers and
`receives the patient's ear. Although not shown, the cover for
`a right ear phone in accordance with the present invention is
`the mirror image of the left ear phone assembly cover
`shown.
`With reference to FIGS. 1 -8, cover 10 includes a proxi-
`mal end 6 and a distal end 8 and is shown having generally
`a D- shape. It should be noted, however, that cover 10 can
`have any shape, e.g., circular, oval, trapezoidal, etc., as well
`as asymmetrical shapes such as the D- shape, that will permit
`the patient's ear to be adequately covered during use. Cover
`10 includes a back wall 19 having a perimeter that joins to
`a side wall 13 to define cavity 50. Cover 10 also includes a
`flange 35 that is connected to side wall 13 and extends
`around the perimeter, and a notch 31 in the flange 35.
`In one embodiment, flange 35 is generally inwardly
`sloped, to provide better conformity to and a better fit
`against the patient's head around the ear, as shown in FIGS.
`2 and 5-8. The flange 35 may extend outwardly from the
`side wall 13. Alternatively, the flange may straddle side wall
`13.
`Notch 31 is positioned along the perimeter 23 of the
`flange 35 to provide easy removal of the disposable element
`20 from the cover, as will be described below. Notch 31 may,
`for example, be positioned at distal end 8 (shown in FIG. 2)
`or midway between distal end 8 and proximal end 6 (not
`shown) or elsewhere in flange 35. In one embodiment, the
`notch 31 is preferably fingertip shaped having a radius.
`However, the notch may be any convenient shape, for
`example, wedge, oval or rectangular, for allowing the user to
`grasp the previously attached disposable element 20.
`It should be understood that, in an alternate embodiment,
`if the thickness of the side wall 13 is sufficiently large, flange
`35 may be omitted.
`Cover 10 is preferably made of a substantially rigid
`material having an acoustical impedance that is higher than
`that of external air. As a result, external acoustical sounds are
`deflected off of cover 10, leaving the cavity 50 sufficiently
`and generally free of ambient and external noise for hearing
`screening. Suitable materials include rubber, elastomers,
`metals and plastics.
`Cover 10 may be formed by injection molding, liquid
`resin casting, or other methods that are well known in the art.
`It may be formed as a unitary piece (e.g., cast, stamped or
`molded) or as an assembly of pieces secured together (e.g.,
`epoxied, glued or welded).
`Preferably, at least back wall 19 is made of a generally
`clear material, for example, a polypropylene or a
`polycarbonate, to provide easy viewing to the user for the
`purpose of proper positioning during operation and to pro-
`tect the patient's ear from ambient noises.
`Advantageously, the materials used and the process of
`manufacturing the cover 10, as discussed above, allow cover
`10 to be cleaned and /or sterilized. Depending on the material
`used, cover 10 may be autoclaved as in the case of a
`polycarbonate. Advantageously too, cover 10 can be rester -
`ilized and re -used numerous times after each hearing screen-
`ing procedure, thereby improving the cost -efficiency of the
`ear phone assembly 3.
`As illustrated in FIGS. 4 -8, the folded or bent portion 29
`is the area to the upper left portion relative to line A of FIG.
`4, and the degree of bending needed to conform the cover
`including the flange to the head is illustrated in the different
`views of the referenced drawings. The bent portion is
`provided with an angle of approximately ten degrees. It
`
`Ex. 2016-0006
`
`

`
`5,913,309
`
`5
`6
`should be understood that the bend is a part of the cover as
`20 may overlap all of flange 35 and extend inwardly beyond
`formed, and is not actually the result of straining the cover
`the dimensions of flange 35. One of the V- shaped projections
`10, although the latter also could occur.
`37 preferably extends over notch 31 at one end in an exposed
`manner and another of projections 37 engages groove 32 at
`Referring to FIGS. 2 -7, port 30 includes a mass of
`the other end. The exposed projection 37 additionally facili-
`material having an aperture 39 extending therethrough 5
`tates removal of the disposable element 20 from cover 10 by
`which opens into side wa1113, a U- shaped projection 26, and
`peeling it off.
`two beveled projections 32A defining therebetween a recep-
`The adhesives used in disposable element 20 are prefer -
`tack or groove 32. Groove 32 is used to position correctly
`ably pressure sensitive and approved for medical
`the disposable element 20 in superposition on flange 35, as
`will be described. It should be understood that groove 32 10 applications, as are well -known in the art. The adhesive is
`selected to have at least enough strength to stick to the
`need not be a part of port 30, but could be located anywhere
`patient's head, creating an air -tight seal, for hearing
`on or near flange 35 where it can be conveniently used.
`screening, yet be weak enough for easy removal of dispos-
`In operation, port 30 receives a transducer (not shown) a
`able element 20 from engagement with the patient's head
`portion of which passes through aperture 39 into cavity 50.
`without trauma to the patient. In addition, the adhesive
`Transducer 50 may have a ribbed cylinder to provide an
`should be strong enough to create an air -tight seal between
`air -tight friction -fit to the inside of aperture 39. In this
`the disposable element 20 and the cover 10, and allow easy
`regard, aperture 39 is preferably circular in cross -section and
`removal of the disposable element from the cover. Suitable
`cylindrical. A suitable transducer is the product known as the
`adhesives include a hydrogel, such as adhesive product
`Acoustic Transducer Assembly, part no. 040176, available
`#63B distributed by Promeon, and acrylic (acrylate) for
`from Natus Medical Incorporated, San Carlos, Calif., the
`example, double coated medical tapes and transfer adhesives
`assignee thereof, and sold for use with the models ALGO
`such as product numbers 1522, 9874, 1524, and 9879, each
`lETM and ALGO 2TM hearing screening instruments, also
`of which is available from 3M Health Care, St. Paul, Minn.
`available from Natus Medical. It should be understood that
`These tapes may be transparent polyethylene coated films or
`aperture 39 may have any shape that will couple securely,
`polyester fiber based tapes which are generally sold with one
`tightly, and removably to a transducer. Although the trans-
`side covered by a silicone treated Kraft- Glassine paper liner.
`ducer forms no part of the present invention, it is contem-
`The adhesive thus may be affixed to two sides of a sheet of
`plated that the length of the aperture 39 be longer than the
`support material 55 with the liner intact to construct an
`portion of the transducer that is inserted into aperture 39.
`adhesive coated support material. The disposable elements
`This, advantageously, minimizes the likelihood of contact
`3o 20 are then formed from such adhesive coated sheets, as
`between the transducer and the patient's ear, in particular the
`discussed further below.
`pinna.
`In one embodiment, the disposable element 20 is sym-
`The U- shaped projection 26 is proximate to aperture 39
`metrically constructed about a horizontal axis and fully
`and projects from port 30 to engage the transducer and
`interchangeable. By this it is meant that disposable element
`minimize the rotation of the transducer in use, e.g., as a
`20 may be selectively used for the right ear or the left ear,
`result of patient movement. It should be understood that in
`and can be positioned on cover 10 without having to
`place of the U- shaped projection 26, a flange, a plurality of
`differentiate between which adhesive covered side (36 or 40)
`flanges, or a pin and hole assembly, or some other well-
`contacts flange 35, or which of the ends 44 and 46 is to be
`known device for engaging a transducer to minimize rota-
`at the proximal end 6 of cover 10. In this case, the sides 36
`tion relative to cover 10, may be used.
`40 and 40, and the ends 44 and 46 are mirror images of each
`Referring to FIGS. 1 and 9 -10, disposable element 20 has
`other with effectively the same type, quality, and adhesion
`an toroidal or annular structure having a first side 36 and a
`strength characteristics on each side. Thus, either side can be
`second side 40, an external perimeter 42 and an interior
`adhered to the cover 10 (or the head) and a given disposable
`perimeter 37A. Each perimeter is preferably D- shaped.
`element can be used in either orientation for the left ear
`However, the disposable element 20 may be any shape that 45 cover or the right ear cover.
`on the one hand allows the patient's ear to pass through the
`In an alternative embodiment, a hydrogel adhesive may
`interior perimeter 37A, and on the other hand secures to
`be used on the side that is to contact the patient's head, and
`flange 35 of cover 10 for securing the ear phone assembly 3
`an acrylic adhesive used on the side to contact cover 10. In
`to the patient.
`this case, disposable element 20 is not fully interchangeable,
`Preferably, disposable element 20 also has V- shaped pro- so because of the differences in the strength, quality, etc. of the
`jections 37 at its top and bottom, which are used in aligning
`different adhesives on its first and second sides, 36 and 40.
`the disposable element 20 to the cover 10 in the proper
`In this embodiment, one side, namely the side having the
`orientation, as will be discussed. Indeed, projections 37
`hydrogel adhesive, is preferably used to contact the patient's
`define the orientation of disposable element 20 relative to a
`head. This is because the hydrogel has adequate adhesion to
`reference point, such as groove 32, for superposition on 55 tissue, but is easier to remove from the patient than an
`flange 35 in the proper relationship.
`acrylic adhesive. Nevertheless, even in this embodiment,
`In a preferred embodiment, each of the first and second
`disposable element 20 remains interchangeable about its
`sides 36 and 40 comprise an adhesive surface 51 and 53
`ends 44 and 46, due to its symmetry about the horizontal
`respectively (see FIG. 10). The adhesive may be coated on
`axis. Thus, the same disposable element 20 can be used for
`or impregnated into a support material 55, or the support 60 the left ear cover and the right ear cover such that the side
`material 55 can be covered with a double sided adhesive
`having the acrylic adhesive is disposed to couple to the cover
`tape. The adhesive is used to secure one side of disposable
`10.
`element 20 to flange 35. The other side of disposable
`The interchangeability of disposable element 20 is par -
`element 20 is secured by the adhesive to the head.
`ticularly advantageous because it reduces the number of
`Preferably, disposable element 20 has substantially the same 65 components that must be manufactured and maintained in
`shape as flange 35 such that disposable element 20 covers
`inventory, thereby reducing the effective cost for the manu-
`flange 35 entirely. In one embodiment, disposable element
`facture and to the user. Further, by using the asymmetrical
`
`Ex. 2016-0007
`
`

`
`5,913,309
`
`7
`D- shape, an improved cavity 50 shape is obtained for which
`the disposable element 20 has left and right ear interchange-
`ability. This reflects an improvement in acoustic isolation
`over the larger dimensioned cavity of the prior art Liverani
`structure.
`Disposable element 20 is preferably constructed of a
`support material 55 that is a resilient open -celled foam, in
`which air is blocked from freely moving from one side of the
`foam to the other due to the tortuous paths formed by the
`open cell structure of the foam. The air impermeability is
`enhanced by the adhesive coatings on the two sides. The
`open cell foam also is resilient and provides comfort and
`easy conformability to the patient's head. Hence, in a
`preferred embodiment, the disposable element 20 is a tor-
`oidal foam cushion. The opened -cell foam may be any that
`is conventional in the art, for example, polyvinylchloride
`(PVC) foam.
`A closed -cell foam may also be employed as support
`material 55, whereby air cannot pass through the foam. A
`suitable closed -cell foam may be polyethylene foam.
`Thus, by the use of a foamed support material 55, the
`amount of ambient noise capable of passing through the
`disposable element 20 is minimized.
`With reference to FIG. 1, two liners 38 are illustrated,
`each as having a pair of tabs 34 at opposite ends, corre-
`sponding to the pair of projections 37 of the disposable
`element 20. Each liner 38, however, may have any number
`of tabs, e.g, one or more than two. Each liner 38 is preferably
`D- shaped to match the shape of the side of disposable
`element 20, however, it may have any shape that covers the
`adhesive surface 51 or 53 of disposable element 20.
`In packaging, that is prior to use, a first liner 38 covers one
`of the adhesive covered sides of disposable element 20 and
`a second liner 38 covers the other side of disposable element
`20. Liners 38 are provided to keep disposable element 20
`sufficiently free of contamination prior to use. Liner 38 also
`lessens the possibility of the adhesive losing its tackiness or
`strength. Liners 38 are easily removed from sides 36 and 40
`by pressing inwardly on disposable element 20 at projec-
`tions 37, thereby causing tabs 34 to separate from the
`underlying adhesives of disposable element 20.
`Alternatively, the user may pull off each liner 38 by pulling
`back on its tab 34. The liner may be a non -woven fabric,
`such as Tyvek, mylar, or a release paper of the kind well
`known in the art, such as Kraft -Glassine paper, which paper
`is preferably silicone treated. Liner 38 is preferably a release
`paper because it is inexpensive and may be disposed of
`easily. Preferably, the first and second liners 38 are identical
`in structure and are the liners commercially provided with
`the double sided adhesive tape or transfer adhesive applied
`to the two sides of support material 55. Liner 38 may also
`be a split liner whereby the liner is cut along a line into two
`separate liners such as a "crack and peel" liner.
`Referring to FIGS. 2, 3, and 4, groove 32 of port 30 is
`designed to receive one of the projections 37 of disposable
`element 20, preferably after removal of the liner 38 over the
`side to be pressed against flange 35. This is to provide easy
`alignment of disposable element 20 with flange 35. Projec-
`tions 37 are slightly smaller than groove 32 such that the
`projections 37 may be easily inserted and removed during
`alignment. Groove 32 and projections 37 may be of any
`shape, preferably complementary (that is, male and female
`mating) shapes. In a preferred embodiment, the groove 32
`and projections 37 are both generally V- shaped, respectively
`the female and male V- shapes.
`Disposable element 20 is formed by coating both sides of
`a support material 55, e.g., a sheet of foam, with adhesive
`
`8
`and covering the adhesive coated sides with a liner paper,
`either during or after the coating process. The lined foam
`sheet is then processed to obtain the disposable element. For
`example, disposable element 20 is generally constructed
`s using a flat bed or "cookie sheet" technique whereby dis-
`posable element 20 is die -cut from the lined foam sheet of
`material, by a cutter that outlines the general shape of the
`disposable element. This is a technique that is conventional
`in the art. For manufacturing, the disposable element 20 is
`la made thin, for example, from 1/2e" to 1/2", and preferably 1/4",
`thick. Advantageously, this allows the use of fast -rotary die
`cutting which is faster and more economical that the slower
`conventional flatbed or "clicker press" techniques.
`In addition, a "double" die -cut design may be used, as
`15 shown in FIGS. 11 and 12, to provide the disposable element
`with two nested planar annular sheets 71 and 72. Annular
`sheet 71 is outward of annular sheet 72 such that the interior
`opening in disposable element 20 defined by sheet 71 (if
`exposed) is larger than the interior opening defined by the
`20 sheet 72. Sheet 72 is removable such that sheet 71 remains
`in place, thereby allowing to adjust the ear phone assembly
`3 for larger size ears. Multiple die -cuts providing for mul-
`tiple sheets and multiple size openings may also be used.
`Advantageously, use of one or more die -cut(s) in disposable
`25 element 20 minimizes the need to maintain inventory of
`different size disposable elements 20 for different size ears
`and increases manufacturing efficiency. It is noted that the
`die cuts may cut cleanly through the disposable element 20,
`or alternately may perforate the sheet, so that there is some
`30 minor tearing of the foam when annular sheets 71 and 72 are
`separated.
`In operation, the ear phone assembly 3 is assembled as
`follows. The liner 37 from one of the sides of disposable
`element 20 is removed, thus exposing the adhesive on one
`35 side of the disposable element 20. The reusable durable
`cover 10 is obtained clean and /or sterile. Disposable element
`20 is secured to flange 35 of cover 10, by aligning groove 32
`with a projection 37 of disposable element 20, and pressing
`the adhesive against the flange 35. Once positioned, the
`40 remaining liner is removed from the disposable element 20,
`thereby exposing the side of the disposable element for
`engaging the patient's head. A transducer (not shown) is then
`(or initially) inserted into aperture 39. The cover 10 and the
`disposable element 20 are then placed around patient's ear,
`45 such that the mastoid is covered by the bent area 29. The
`disposable element 20 and cover 10, in combination, are
`pressed against the patient's head, forming an ambient noise
`blocking cavity 50 surrounding the ear, thereby allowing the
`transducer to couple sufficiently free of external noise.
`Further, port 30 may be located in a location that is
`different from what is illustrated in the drawings, for
`example, in back wall 19. Alternatively, the port could be
`located in disposable element 20 to open directly into cavity
`50, such that the transducer portion inserted into disposable
`element 20 provides a good seal to minimize any ambient
`noise entering the cavity 50.
`It will be appreciated that the present invention may be
`used with conventional hearing screening equipment as is
`60 wellknown in the art. For example, the models ALGO 1ETM
`and ALGO 2 hearing screening machines available from
`Natus Medical, as well as otacoustic emission based
`machines.
`The present invention has several advantages over the
`65 prior art including that it is easily manufactured, cost -
`effective whereby the cover is reusable and less disposable
`material is used as compared to prior devices, and allows for
`
`so
`
`Ex. 2016-0008
`
`

`
`5,913,309
`
`9
`adjustment of the ear phone assembly for different ear sizes.
`Moreover, the ear phone of the present invention is simple,
`lightweight, and safe for use with infants.
`The present invention has been described in terms of the
`preferred embodiments of the invention, which are pre-
`sented for purposes of illustration and not of limitation. It
`will be appreciated that modifications, variations, and fea-
`tures within the scope of the invention, given the benefit of
`the disclosure, will occur to one of ordinary skill in the art.
`We claim:
`1. A disposable element for use with an ear phone system
`for hearing screening, comprising:
`an annular sheet of a support material having a first side
`and a s