BAHA DIVINO

K042017 · Entific Medical Systems, Inc. · LXB · Aug 26, 2004 · Ear, Nose, Throat

Device Facts

• Record ID: K042017
• Device Name: BAHA DIVINO
• Applicant: Entific Medical Systems, Inc.
• Product Code: LXB · Ear, Nose, Throat
• Decision Date: Aug 26, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3302
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BAHA Divino is intended for the following patients and indications: - Patients who have a conductive or mixed hearing loss and can still benefit from sound amplification. The pure tone average bone conduction threshold should be better than or equal to 45 dB HL (measured at 0.5, 1, 2 and 3 kHz) - Bilateral fitting of the Divino is intended for patients who suffer from moderate to severe bilateral symmetric conductive and/or mixed hearing losses. Symmetric bone conductive thresholds are defined as less than 10 dB in average (measured at 0.5, 1, 2 and 4 kHz) or less than 15 dB at individual frequencies - The single sided deafness (SSD) indication for the Divino 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.

Device Story

BAHA Divino is a bone conduction hearing aid. Device connects to a surgically implanted titanium fixture pillar in the skull bone behind the deaf ear. Unlike air conduction aids, it transmits sound via bone vibration directly to the cochlea. Used by patients with conductive/mixed hearing loss or single-sided deafness. Device processes sound digitally to provide amplification. Healthcare providers fit the device to the patient. Benefits include improved hearing for those unable to use conventional air conduction aids.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing and software validation to confirm functional equivalence to predicate devices.

Technological Characteristics

Bone conduction hearing aid. Implant: Titanium; Abutment snap: PEEK. Power: Zinc-air battery. Max gain: 33dB. Frequency response: 125 Hz - 8 KHz. Sound processing: Digital. Form factor: Bone-anchored processor.

Indications for Use

Indicated for patients with conductive or mixed hearing loss (bone conduction threshold ≤ 45 dB HL); bilateral symmetric conductive/mixed hearing loss; or unilateral sensorineural deafness (SSD) with normal hearing in the contralateral ear (PTA AC threshold ≤ 20 dB). Also indicated for patients requiring AC CROS who 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

• BAHA (K955713)
• BAHA (K984162)
• BAHA (K011438)
• BAHA (K021837)

Submission Summary (Full Text)

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# 1042017

# AUG 2 6 2004

# SECTION 0. 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 G\u00f6teborg<br>Sweden |
| CONTACT PERSON: | Constance Bundy |
| TELEPHONE NUMBER: | 763-574-1976 |
| FAX NUMBER: | 763-574-2437 |
| DATE OF SUBMISSION: | July 26, 2004 |

#### 1. Identification of device

Proprietary Name: BAHA Divino® Common Name: Hearing Aid, Bone Conduction Classification Status: Class II per regulations 21 CFR & 874.3300 Product Codes: LXB

#### 2. Equivalent devices

Entific Medical Systems believes that the BAHA Divino has substantially equivalent technology as air conduction hearing aids with digital sound processing (exempt from 510(k)) and, regarding intended use, function and fitting procedure, is equivalent to previous models of BAHA cleared in 510(k) K955713, K984162, K011438 and K021837.

#### 3. Description of the Device

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

The Divino 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.

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#### 4. Intended use

The BAHA Divino is intended for the following patients and indications:

- Patients who have a conductive or mixed hearing loss and can still benefit from sound amplification. The pure tone average bone conduction threshold should be better than or equal to 45 dB HL (measured at 0.5, 1, 2 and 3 kHz)

- Bilateral fitting of the Divino is intended for patients who suffer from moderate to severe bilateral symmetric conductive and/or mixed hearing losses. Symmetric bone conductive thresholds are defined as less than 10 dB in average (measured at 0.5, 1, 2 and 4 kHz) or less than 15 dB at individual frequencies

- The single sided deafness (SSD) indication for the Divino 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.

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

### Comparison table

| Characteristic | BAHA -Branemark<br>Bone Anchored<br>Hearing aid | Air conduction<br>Hearing Aids with<br>digital sound<br>processing | BAHA Divino |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|----------------------------|
| Material | Implant: Titanium<br>Abutment Snap:<br>PEEK | Multiple | Same as BAHA |
| Intended use | Improvement of<br>hearing for patients<br>with conductive and<br>mixed hearing losses,<br>bilateral fitting and<br>single sided deafness | Improvement of<br>hearing | Same as BAHA |
| Power<br>requirement | Zinc-air | N/A | Same as BAHA |
| Max gain | 33dB | N/A | Same as BAHA |
| Frequency<br>response | 125 Hz - 8 KHz | N/A | Same as BAHA |
| Sound<br>processing | Analogue | Digital | Digital |
| Manufacturer | Entific Medical<br>Systems | N/A | Entific Medical<br>Systems |
| K-number | K955713, K984162,<br>K011438 and<br>K021837 | Exempt | Pending |

#### 6. Discussion of testing

Testing of the BAHA Divino included software validation and functional testing. These tests verify that the Divino is functionally equivalent to the BAHA.

#### 7. Conclusion

It is the conclusion of Entific Medical Systems that the BAHA Divino with digital sound processing 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.

:

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing and body. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the logo.

### Public Health Service

Food and Drug Administration Rockville MD 20857

AUG 2 6 2004

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

Re: K042017

Trade/Device Name: BAHA Divino® Regulation Number: 21 CFR 874.3300 Regulation Name: Bone Conduction Hearing Aid Regulatory Class: Class II Product Code: LXB Dated: July 26, 2004 Received: July 27, 2004

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.

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Page 2 - Ms. 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), 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/dsma/dsmamain.html

Sincerely yours,

A kalgi korenthal

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

Enclosure

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## B. INDICATIONS FOR USE

Koy 2017 510(k) Number

Device Name: BAHA Divino®

### Indications for Use:

The BAHA Divino is intended for the following patients and indications:

- Patients who have a conductive or mixed hearing loss and can still benefit from sound amplification. The pure tone average bone conduction threshold should be better than or equal to 45 dB HL (measured at 0.5, 1, 2 and 3 kHz)

- Bilateral fitting of the Divino is intended for patients who suffer from moderate to severe bilateral symmetric conductive and/or mixed hearing losses. Symmetric bone conductive thresholds are defined as less than 10 dB in average (measured at 0.5, 1, 2 and 4 kHz) or less than 15 dB at individual frequencies

- The single sided deafness (SSD) indication for the Divino 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over the Counter Use -------

Kaiser Schlin

510(k) Number K042017