JAZZ PP AGC-O, JAZZ PP

K972542 · Trutone · ESD · Jul 23, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K972542
• Device Name: JAZZ PP AGC-O, JAZZ PP
• Applicant: Trutone
• Product Code: ESD · Ear, Nose, Throat
• Decision Date: Jul 23, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3300
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)): Severity: 1. Slight 2. Mild 3. Moderate 4. Severe 5. Profound Configuration: 1. High Frequency - Precipitously Sloping 2. Gradually Sloping 3. Reverse Slope 4. Flat 5. Other Other: 1. Low tolerance To Loudness 2. JAZZ PP AGC-C

Device Story

Air conduction hearing aids (Jazz PP AGC-O, Jazz PP) designed to amplify sound for individuals with impaired hearing. Devices function by capturing ambient sound and providing amplification tailored to user hearing loss profiles, specifically addressing severe loss and low tolerance to loudness. Used by patients with hearing impairment; operated by the wearer. Output is amplified acoustic signal delivered to the ear canal. Assists in improving auditory perception for the patient.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Air conduction hearing aid; includes Automatic Gain Control (AGC) circuitry for sound processing. Class I device (21 CFR 874.3300).

Indications for Use

Indicated for individuals with impaired hearing, specifically those with severe hearing loss, flat hearing loss configurations, and low tolerance to loudness.

Regulatory Classification

Identification

An air-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. An air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. The air-conduction hearing aid generic type excludes the group hearing aid or group auditory trainer, master hearing aid, and the tinnitus masker, regulated under §§ 874.3320, 874.3330, and 874.3400, respectively.

Submission Summary (Full Text)

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

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three wing-like shapes, representing health and human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ziad Shwiyat Technical Manager Trutone Ltd. 3113 S. 115th E. Avenue Tulsa, OK 74146 U.S.A.

Dear Mr. Shwiyat:

Re: K972542 Jazz PP AGC-O, Jazz PP Dated: July 9, 1997 Received: July 9, 1997 Regulatory class: I 21 CFR 874.3300/Procode: 77 ESD

## JUL 2 3 1997

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Eederal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

While your device has been deemed substantially equivalent to other legally marketed hearing aids, please be advised that electromagnetic interference from digital cellular telephones, as well as from other sources is increasingly becoming a concern. Typically, this interference takes the form of a buzzing sound that can range from annoying to very loud and may render a hearing aid temporarily ineffective for the wearer. Because electromagnetic interference may affect your may be asked to test for eiectromagnetic compatibility in the future. In this interim period, we encourage you to modify your device labeling to inform practitioners and users of the potential for electromagnetic interference. Please be aware that a 510(k) submission is required for any claims that infer that your device is compatible with potential sources of electromagnetic interference, such as "compatible with digital cellular telephones", and that data supporting such claims is necessary.

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

Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the...... . ..... ... Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its = ============================================================== Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Willian Yin

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

| 510(k) Number (if known): | K972542 | Page ___ of ___ |
|---------------------------|-------------------------------|-----------------|
| Device Name: | 1. JAZZ PP AGC-C , 2. JAZZ PP | |

Indications For Use:

A. General Indications:

The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)):

| Severity: | Configuration: | Other |
|-------------|-------------------------------------------|--------------------------------|
| 1. Slight | 1. High Frequency - Precipitously Sloping | ✓ 1. Low tolerance To Loudness |
| 2. Mild | 2. Gradually Sloping | 2. JAZZ PP AGC-C |
| 3. Moderate | 3. Reverse Slope | 3. |
| ✓ 4. Severe | ✓ 4. Flat | |
| 5. Profound | 5. Other | |

B. Specific Indications (Only if appropriate.):

(Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.)

1.

2.

3.

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT,

Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number_ K972542

Restricted device (per 21 CFR 801.420 & 21 CFR 801.421)

.