D72 DIGITAL

K972818 · Philips Hearing Instruments Co. · ESD · Oct 17, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K972818
• Device Name: D72 DIGITAL
• Applicant: Philips Hearing Instruments Co.
• Product Code: ESD · Ear, Nose, Throat
• Decision Date: Oct 17, 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 hearing. The devices are indicated for individuals with losses in hearing. The devices are indicated for individuals with losses in hearing and can be used for: Severity: Slight, Mild, Moderate, Severe; Configuration: High Frequency - Precipitously Sloping, Gradually Sloping, Reverse Slope, Flat; Other: Low tolerance To Loudness.

Device Story

The Philips D72 Digital is an air conduction hearing aid designed to amplify sound for individuals with hearing impairment. It processes acoustic input to compensate for specific hearing loss configurations and loudness tolerance issues. The device is intended for use by patients with diagnosed hearing loss. It functions as a wearable hearing aid, providing amplification to improve auditory perception. Healthcare providers, such as audiologists or hearing instrument specialists, typically fit and adjust the device to the patient's specific audiometric profile. The output is amplified sound delivered directly to the ear canal, intended to assist the patient in daily communication and environmental sound awareness.

Clinical Evidence

No clinical data provided; substantial equivalence is based on regulatory classification and comparison to legally marketed hearing aids.

Technological Characteristics

Air conduction hearing aid; digital signal processing; intended for slight to severe hearing loss; restricted device per 21 CFR 801.420 and 801.421.

Indications for Use

Indicated for individuals with slight to severe hearing loss, including high frequency precipitously sloping, gradually sloping, reverse slope, and flat configurations, as well as patients with 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)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 17 1997

Ted Miksiewicz Manager, Service & Logistics Philips Hearing Instruments Company A Division of Philips Electronics North America Corporation 91 McKee Drive Mahwah, New Jersey 07430

Re:

K972818 D72 Digital (Hearing Aid) Dated: July 25, 1997 Received: July 29, 1997 Regulatory class: I 21 CFR 874.3300/Procode: 77ESD

Dear Mr. Miksiewicz

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 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 device, you may be asked to test for electromagnetic 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.

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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,

Sincerely yours,

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

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:

(972818 510(k) Number (if known):

Device Name: *PHILIPS 072 DIGITAL*

Indications For Use:

...........

A. General Indications:

The indication for use of the air conduction hearing aids in this The indication for use of the are individuals with impaired submission is to ampiriy some indicated for individuals with losses in
hearing. The devices are indicated for individuals with losses in
thearing. The devices are indicated a nearing. The devices are indicated ass and and can and

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

B. Specific Indications (Only if appropriate.):

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

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Concurrence of CPRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Dev 510(k) Number

Restricted device (per 21 CFR 801.420 & 21 CFR 301.421)