DUALINE 400 CIC

K971158 · Bernafon-Maico, Inc. · ESD · Jun 13, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K971158
• Device Name: DUALINE 400 CIC
• Applicant: Bernafon-Maico, Inc.
• Product Code: ESD · Ear, Nose, Throat
• Decision Date: Jun 13, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3300
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The intended use of this model hearing aid is to amplify sound pressure waves and transmit the signal to the external ear, through the medium of air, to compensate for impaired hearing. This device is indicated for individuals with losses in the following categories: 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

Device Story

DUALINE 400 CIC is a hearing aid designed to amplify sound pressure waves and transmit them to the external ear via air conduction. Device compensates for impaired hearing across various severity levels and configurations. Operated by the patient; intended for daily use. Device processes acoustic input to provide amplification tailored to user hearing loss. Benefits include improved auditory perception for individuals with hearing impairment. Clinical utility involves compensating for hearing deficits; healthcare providers use device output to address patient hearing needs.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Hearing aid device; CIC (Completely-in-Canal) form factor. Amplification of sound pressure waves via air conduction. Class I device under 21 CFR 874.3300.

Indications for Use

Indicated for individuals with slight to profound hearing loss, including high frequency precipitously sloping, gradually sloping, reverse slope, flat, or other configurations, and those 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUN 13 1997

Re: K971158
Due: 400 CIC
Dated: March 25, 1997
Received: March 28, 1997
Regulatory class: I
21 CFR 874.3300/Procode: 77 ESD

Raymond A. Enroth
Manager of Regulatory Affairs & Quality Enhancement
Bernafon-Maico, Inc.
9675 West 76th Street
Eden Prairie, MN 55344

Dear Mr. Enroth:

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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 Federal 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 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), 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 at [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Enclosure

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Page 1 of 1

510 (k) Number (if know): K 971158

Device Name: DUALINE 400 CIC

Indications For Use:

A. General Indications:

The intended use of this model hearing aid is to amplify sound pressure waves and transmit the signal to the external ear, through the medium of air, to compensate for impaired hearing. This device is indicated for individuals with losses in the following categories:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David L. Seyman
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K971158

Prescription Use (Per 21 CFR 801.109)
OR
Over - The - Counter Use
(Optional Format 1 - 2 - 96)

Restricted Device