TRANSEAR BONE CONDUCTION HEARING AID

K050653 · United Hearing Systems, Inc. · LXB · Jul 1, 2005 · Ear, Nose, Throat

Device Facts

• Record ID: K050653
• Device Name: TRANSEAR BONE CONDUCTION HEARING AID
• Applicant: United Hearing Systems, Inc.
• Product Code: LXB · Ear, Nose, Throat
• Decision Date: Jul 1, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3302
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TransEAR™ Bone Conduction Hearing Aid is indicated for persons with single sided deafness to provide the perception of sound from the deaf ear. The amplified signal is received into the deaf ear and transferred through the bones of the skull to the better cochlea.

Device Story

TransEAR™ is a bone conduction hearing aid for patients with single-sided deafness. Device consists of a digital sound processor (housed in a behind-the-ear unit) and a mechanical transducer (oscillator) connected by a wire cable. The transducer is embedded in a custom-made ear mold. The device captures sound, processes it digitally, and converts it into mechanical vibrations; these vibrations are transmitted through the skull bones to the patient's functioning cochlea. The device is worn by the patient; the ear mold is custom-fitted from an impression of the wearer's ear. Power is provided by a standard Zinc-Air battery. The device aims to provide sound perception from the deaf side, potentially improving auditory awareness.

Clinical Evidence

Bench testing only. No clinical data provided. Functional testing confirmed performance equivalence to predicate devices.

Technological Characteristics

Bone conduction hearing aid; digital sound processor; mechanical oscillator transducer; custom ear mold; Zinc-Air battery (675, 10A, or 13) power source; behind-the-ear form factor; biocompatible materials.

Indications for Use

Indicated for persons with single-sided deafness to provide sound perception from the deaf ear by transferring amplified signals through skull bones to the functioning cochlea.

Regulatory Classification

Identification

A bone-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing and that conducts sound to the inner ear through the skull. The non-implantable components of a bone-conduction hearing aid, such as the external sound processor, are subject to the requirements in § 801.422 of this chapter.

Predicate Devices

• Starkey Model BC1 Bone Conduction CROS Hearing Aid (K923784)
• Unitron® Bone Conduction Hearing Aid (K884288)
• Second Ear® Bone Conduction Hearing Aid (K953872)
• Branemark Bone Anchored Hearing Aid (BAHA) (K021837, K042017)

Submission Summary (Full Text)

{0}------------------------------------------------

K050653

## United Hearing Systems 510(k) Premarket Notification TransEAR™ Bone Conduction Hearing Aid

### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS IV.

#### Applicant Name, Address, and Contact: 1.

United Hearing Systems, Inc. 137 Norwich Road Central Village, CT 06332 Tel: [phone] Fax: [phone] e-mail: [e-mail]

Ralph Campagna Contact:

| Date Prepared: | March 7, 2005 |
|----------------|-----------------|
| Prepared by: | Melissa Mazzoni |

### Identification of the Device 2.

| Proprietary Name: | TransEART™ Bone Conduction Hearing Aid |
|-------------------|----------------------------------------|
| Common Name: | Bone Conduction Hearing Aid |
| Classification: | Class II |
| CFR Section No: | 874.3300 |
| Product Code: | LXB |

#### Device Description: 3.

TransEAR™ is a bone conduction hearing aid. Unlike conventional air-conduction hearing aids, which depend on acoustic coupling through the air, TransEAR™ utilizes bone conduction technology to transmit sound vibrations through the bones of the skull to the cochlea.

TransEAR™ consists of a processor and a transducer (oscillator) connected via a wire cable. TransEAR's processor uses conventional digital hearing aid technology housed in a conventional behind-the-ear aid housing. The transducer is a mechanical oscillator housed in a conventional ear mold made of standard ear mold material. Each ear mold is custom made from an impression of the wearer's ear. A standard Zinc-Air hearing aid battery is utilized for power.

### Technological Characteristic of Substantially Equivalent Device(s): র্বা

The TransEAR™ is substantially equivalent to the following devices:

- Starkey Model BC1 Bone Conduction CROS Hearing Aid a
- Unitron® Bone Conduction Hearing Aid 公
- Second Ear® Bone Conduction Hearing Aid A
- Branemark Bone Anchored Hearing Aid (BAHA) A
- Various behind-the-ear air conduction hearing aids consisting of a digital A sound processor and standard ear mold.

{1}------------------------------------------------

# United Hearing Systems 510(k) Premarket Notification TransEAR™ Bone Conduction Hearing Aid

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

| Characteristic | TransEAR Bone<br>Conduction<br>Hearing Aid<br>Pending | Starkey BC1 Bone<br>Conduction CROS<br>Hearing Aid<br>K923784 | Unitron Bone<br>Conduction<br>Hearing Aid<br>K884288 | Second Ear Bone<br>Conduction<br>Hearing Aid<br>K953872 | BAHA<br>K021837<br>K042017 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) No. | Pending | K923784 | K884288 | K953872 | K021837<br>K042017 |
| Design | Bone conduction<br>hearing aid<br>consisting of a<br>processor and a<br>transducer<br>(oscillator)<br>connected via a<br>small wire cable.<br>Vibrator is housed<br>in a standard<br>earmold. | Bone conduction<br>hearing aid<br>consisting of a<br>processor and<br>oscillator.<br>Oscillator is<br>connected via cord<br>to microphone and<br>amplifier housed in<br>a headband. | Bone conduction<br>hearing aid<br>consisting of a<br>processor and<br>oscillator.<br>Processor is<br>connected to an<br>oscillator by a cord<br>attached to a<br>headband. | Bone conduction<br>hearing aid<br>consisting of a<br>processor and a<br>oscillator connected<br>via a small wire<br>cable. The<br>oscillator is held<br>against the skull<br>with a headband or<br>strap. | Bone conduction<br>hearing aid<br>connected to a<br>fixture pillar, which<br>has been surgically<br>placed in the bone<br>behind the deaf ear. |
| Intended Use | To transmit sound<br>through the skull<br>bones for hearing. | Same | Same | Same | Same |
| Indications for<br>Use | Indicated for<br>persons with single<br>sided deafness to<br>provide the<br>perception of<br>sound from the<br>deaf ear. The<br>amplified signal is<br>received into the<br>deaf ear and<br>transferred through<br>the bones of the<br>skull to the better<br>cochlea. | Indicated for<br>patients with<br>conductive hearing<br>losses and normal<br>bone conduction<br>hearing.<br>Particularly useful<br>for those with<br>congenital atresia<br>and require bone<br>conduction<br>amplification. | Indicated for<br>moderate to severe<br>conductive and<br>mixed hearing<br>losses that are<br>complicated by<br>congenital or<br>accidental blockage<br>of air conduction<br>pathways. | Indicated for<br>moderate to severe<br>conductive hearing<br>losses. Particularly<br>useful for<br>conductive losses<br>compounded by<br>congenital or<br>secondary<br>obstruction of<br>auditory air<br>conduction<br>mechanisms. | The BAHA for<br>single sided<br>deafness (SSD) is<br>indicated for<br>patients who suffer<br>from unilateral<br>sensorineural<br>deafness.<br>Transmits sound<br>from the deaf side<br>through the bones<br>in the skull to the<br>normal functioning<br>cochlea and is<br>intended to<br>improve speech<br>recognition. |
| Materials | Biocompatible<br>standard materials<br>utilized in the<br>hearing health<br>industry. | Same | Same | Same | Same |
| Energy Source | Zinc-Air battery<br>(675, 10A, or 13) | Same | Same | 4.8 VDC Nickel-<br>metal- hydride<br>rechargeable<br>battery | Same |

### Table 1: Comparison Table

{2}------------------------------------------------

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

### Functional Testing 5.

Functional testing of the TransEAR™ Bone Conduction Hearing Aid was conducted. Results of this testing indicate that the TransEAR™ is substantially equivalent to the predicate devices.

### Conclusion 6.

It is the conclusion of United Hearing System, Inc. that the TransEAR™ Bone Conduction Hearing Aid is substantially equivalent to the predicated devices in terms of intended use, function, design, materials and performance. Additionally, United Hearing Systems concludes that there are no new concerns regarding safety and effectiveness of the device.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The text is in all caps and appears to be in a sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 - 2005

United Hearing Systems, Inc. c/o Ralph T. Campagna - CEO 137 Norwich Road Central Village, CT 06332

Re: K050653

Trade/Device Name: TransEAR™ Bone Conduction Hearing Aid Regulation Number: 21 CFR 874.3300 Regulation Name: Hearing aid Regulatory Class: Class II Product Code: LXB Dated: June 23, 2005 Received: June 24, 2005

Dear Mr. Campagna:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{4}------------------------------------------------

### Page 2 - Ralph T. Campagna

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

David M. Whipple

David M. Whipple Acting Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

## United Hearing Systems 510(k) Premarket Notification TransEAR™ Bone Conduction Hearing Aid

### III. INDICATIONS FOR USE

| 510(k) Number: | K050653 |
|----------------|---------|
|----------------|---------|

TransEAR™ Bone Conduction Hearing Aid Device Name:

Indications for Use:

The TransEAR™ Bone Conduction Hearing Aid is indicated for persons with single sided deafness to provide the perception of sound from the deaf ear. The amplified signal is received into the deaf ear and transferred through the bones of the skull to the better cochlea.

(Please do not write below this line - continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:
(Per 21CFR 801.109)

OR

Over the Counter Use:

Amalolt

Division Sign-

510(k) Number