BRANENMARK BONE-ANCHORED-HEARING AID (BAHA)

K021837 · Entific Medical Systems, Inc. · LXB · Aug 30, 2002 · Ear, Nose, Throat

Device Facts

• Record ID: K021837
• Device Name: BRANENMARK BONE-ANCHORED-HEARING AID (BAHA)
• Applicant: Entific Medical Systems, Inc.
• Product Code: LXB · Ear, Nose, Throat
• Decision Date: Aug 30, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3302
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

BAHA hearing aid for SSD is intended for patients who suffer from unilateral sensorineural deafness. BAHA hearing aid transmits the sound from the deaf side through the bones in the skull to the normal functioning cochlea and is intended to improve speech recognition.

Device Story

The BAHA is a bone-conduction hearing aid for patients with unilateral sensorineural deafness. It consists of a sound processor connected to a surgically implanted titanium fixture pillar in the bone behind the deaf ear. The device captures sound and converts it into mechanical vibrations, which are transmitted through the skull bones to the cochlea of the functioning ear. This bypasses the deaf ear, allowing the patient to perceive sound from the impaired side. The device is used in clinical settings and by patients in daily life. It aims to improve speech recognition in noise. Clinical benefit is established via audiometric evaluation and subjective questionnaires (APHAB).

Clinical Evidence

Clinical study conducted to evaluate benefits for SSD patients. Study utilized audiometric evaluation of speech perception in noise and the Abbreviated Profile of Hearing Aid Benefit (APHAB) subjective questionnaire.

Technological Characteristics

Bone conduction hearing aid. Implant: Titanium; Abutment snap: PEEK. Power source: Zinc-air battery. Max gain: 33dB. Frequency response: 125 Hz - 8 kHz. System utilizes a surgically placed fixture pillar for osseointegration.

Indications for Use

Indicated for patients with unilateral sensorineural deafness and normal hearing in the contralateral ear (PTA AC threshold ≤ 20dB at 0.5, 1, 2, and 3 kHz). Also indicated for patients who are candidates for an air conduction (AC) CROS hearing aid but cannot or will not use one.

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

• Branemark BAHA (K955713)

Reference Devices

• Air conduction hearing aids with a CROS unit

Submission Summary (Full Text)

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

K021837

## SECTION 2. SUMMARY AND CERTIFICATION

### A. 510(K) SUMMARY

### Summary of Safety and Effectiveness

| SUBMITTER'S NAME: | Entific Medical Systems |
|---------------------|------------------------------------------------|
| ADDRESS: | P:O: Box 16024<br>SE-412 21 Göteborg<br>Sweden |
| CONTACT PERSON: | Constance Bundy |
| TELEPHONE NUMBER: | 763-574-1976 |
| FAX NUMBER: | 763-574-2437 |
| DATE OF SUBMISSION: | June 1. 2002 |

#### 1. Identification of device

Proprietary Name: Branemark Bone Anchored Hearing Aid Common Name: BAHA™M Classification Status: Class II per regulations 21 CFR § 874.3300 Product Codes: LXB

#### 2. Equivalent devices

Entific Medical Systems believes that the single sided deafness (SSD) indication for BAHA hearing aid is substantially equivalent regarding intended use to air conduction hearing aids with a CROS unit (exempt from 510(k)). The BAHA device and its fitting procedure is identical to the Branemark BAHA cleared in 510(k) 955713.

#### 3. Description of the Device

The BAHA is a bone conduction-type hearing aid. Unlike conventional hearing aids, which depend on acoustic coupling through the air, the BAHA is based on a bone conduction technology.

The BAHA hearing aid is connected to a fixture pillar, which has been surgically placed in the bone behind the deaf ear. Sound is transmitted through the bones of the skull to the hearing ear with the normal functioning cochlea.

#### 4. Intended use

BAHA hearing aid for SSD is intended for patients who suffer from unilateral sensorineural deafness.

BAHA hearing aid transmits the sound from the deaf side through the bones in the skull to the normal functioning cochlea and is intended to improve speech recognition.

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

#### Technological characteristics, comparison to predicate device. ડ.

### Comparison table

| Characteristic | BAHA for single<br>sided deafness<br>(SSD) | Air conduction<br>Hearing Aids with<br>CROS unit | BAHA - Branemark<br>Bone Anchored<br>Hearing aid | S/Eq |
|------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------|------|
| Material | Same as BAHA | Multiple | Implant: Titanium<br>Abutment Snap:<br>PEEK | Yes |
| Intended use | Improvement of<br>hearing and speech<br>recognition for SSD<br>patients | Improvement of<br>hearing and speech<br>recognition for SSD<br>patients | Improvement of<br>hearing for patients<br>with conductive and<br>mixed hearing losses | Yes |
| Power<br>requirement | Same as BAHA | N/A | Zinc-air | Yes |
| Max gain | Same as BAHA | N/A | 33dB | Yes |
| Frequency<br>response | Same as BAHA | N/A | 125 Hz - 8KHz | Yes |
| Manufacturer | Entific Medical<br>Systems | N/A | Entific Medical<br>Systems | |
| Classification<br>code | LXB | ESD | LXB | |
| K-number | Pending | Exempt | K955713 | |

CROS = Contra-lateral Routing Of Signals

#### 6. Discussion of testing

A clinical study was conducted to establish the benefits of BAHA for SSD including audiometric evaluation of speech perception in noise as well as a subjective questionnaire (APHAB).

#### 7. Conclusion

It is the conclusion of Entific Medical Systems that the BAHA for SSD is substantially equivalent to devices already on the market, both cleared by and exempt from the 510(k) process and presents no new concerns about safety and effectiveness.

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

### B. TRUTH AND ACCURACY CERTIFICATION, BAHA FOR SINGLE SIDED DEAFNESS

I certify that, in my capacity as Quality and Regulatory Manager, I believe, to the best of my knowledge, that all data and information submitted in this premarket notification are truthful and accurate, and that no material fact has been omitted.

8

Fan Callentrat

Quality and Regulatory Manager, Entific Medical Systems

May 24, 2002 Date

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

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right, with flowing lines beneath them. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### AUG 3 0 2002

Entific Medical Systems c/o Constance Bundy Regulatory Consultant to Entific Medical Systems C.G. Bundy Associates, Inc. 6740 Riverview Terrace Minneapolis, MN 55432

Re: K021837

Trade/Device Name: BRANEMARK Bone-Anchored-Hearing Aid (BAHA™) for Single Sided Deafness (SSD)

Regulation Number: 874.3300 Regulation Name: Hearing Aid Regulatory Class: Class II Product Code: LXB Dated: June 1, 2002 Received: June 4, 2002

Dear Ms. Bundy:

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 - Constance Bundy

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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

# B. INDICATIONS FOR USE

510(k) Number K021837

Device Name: The BRÅNEMARK Bone-Anchored-Hearing Aid (BAHATM).

### Indications for Use:

The use of BAHA hearing aid for SSD is intended to improve speech recognition.

The single sided deafness (SSD) indication for BAHA hearing aid is intended for patients who suffer from unilateral sensorineural deafness on one ear while the other ear has normal hearing. Normal hearing is defined as PTA AC threshold equal to or better than 20dB measured at 0.5, 1, 2 and 3 kHz.

BAHA for SSD is also indicated for patients who are indicated for an AC CROS but who for some reason cannot or will not use an AC CROS.

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|-------------------------------------------------------------------------|----------------------|
| (Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises | |
| 510(k) Number | K021837 |
| Prescription Use (Per 21 CFR 801.109) | <div></div> |
| | OR |
| | Over the Counter Use |
| Prescription Use (Per 21 CFR 801.109) | <div></div> |

(Please do not write below this line - continue on another page if needed)