RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER)

K974257 · Resound Corp. · ESD · Dec 12, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K974257
• Device Name: RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER)
• Applicant: Resound Corp.
• Product Code: ESD · Ear, Nose, Throat
• Decision Date: Dec 12, 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

Device Story

Air-conduction behind-the-ear hearing instrument; amplifies sound pressure waves; transmits signal to external ear via air. Powered by type 13 battery. Programmed by hearing health care professional using Noah-based ReSound ReSource software; supports up to 4 programs per ear. Device is remote control/programmer dependent; does not retain programs when powered off. Used in clinical settings by hearing health care professionals to compensate for hearing loss; benefits patient by improving sound perception.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, intended use, and performance specifications identical to the predicate device.

Technological Characteristics

Air-conduction behind-the-ear hearing instrument. Powered by type 13 battery. Utilizes standard manufacturing materials and techniques. Features Direct Audio Input (DAI) option. Programmable via external Noah-based software. No specific ASTM standards cited.

Indications for Use

Indicated for individuals with mild to severe hearing loss, including high frequency precipitously sloping 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.

Predicate Devices

• ReSound® BT4 Personal Hearing System™ (K964557)

Submission Summary (Full Text)

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K974257
DEC 12 1997

## ReSound® Digital 2000-BT

## SUMMARY OF SAFETY AND EFFECTIVENESS

Substantial equivalence for the ReSound® Digital 2000-BT to the predicate device, the ReSound® BT4 Personal Hearing System™, 510(k) No. K964557, November 27, 1996, is based on the following:

- This air-conduction behind-the-ear hearing instrument, intended to amplify sound . pressure waves and transmit the signal to the external ear through the medium of air, is designed to compensate for hearing losses from mild to severe.
- The device is powered by a standard hearing aid battery (type 13). .
- The device is manufactured and delivered completely assembled to the hearing aid . dispenser using materials and techniques widely used by other manufacturers of hearing devices.
- The intended use, performance specifications, functions and operations of the . ReSound® Digital 2000-BT are essentially identical to that described in the 510(k) Premarket Notification for the ReSound® BT4 Personal Hearing System™
- The predicate device has the ability to retain programs in memory, and, with the use of . the optional remote control, up to three programs are accessible. The ReSound® Digital 2000-BT, however, is remote control/programmer dependent, therefore, no programs are retained in the device if the device is turned off. The ReSound® Digital 2000-DP is programmed by the hearing health care professional with up to 4 different programs per ear via Noah based ReSound ReSource™ software.
- . The operation and functioning of the DAI option is identical to that offered by other hearing aid manufacturers.

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Image /page/1/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure, with three overlapping profiles suggesting a sense of community or interconnectedness. The profiles are rendered in a flowing, abstract manner. Encircling the figure is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 2 1997

Krista M. Buckles, M.A., CCC-A Principle Consultants clo Rocky Mountain Regulatory Consulting Resound® Hearing Health Care 220 Saginaw Drive Seaport Centre Redwood City, CA 94063

Re:

K974257 ReSound® Digital 2000-BT with ReSound® Digital 2000-DP (Digital Programmer) Dated: November 11, 1997 Received: November 13, 1997 Regulatory class: I 21 CFR 874.3300/Procode: 77ESD

Dear Ms. Buckles:

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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 incffective 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 notential 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, 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

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| 510(k) Number (if known): | K974257 | | | | Page 1 of 1 |
|---------------------------|-------------------------|--|--|--|-------------|
| Device Name: | ReSound Digital 2000-BT | | | | |

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. __________ |
| ✗ 3. Moderate | ✗ 3. Reverse Slope | 3. __________ |
| X 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. __________

(PLRAS 2 DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence (at CDRH, Office of Device Evaluation (ODE) | <div> <img alt="Signature" src="signature.png"/> </div> |
|--------------------------------------------------------------------|---------------------------------------------------------|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K974257 |

Sescribted device (per 21 Cal 801.410 & 21 Caa 801.421)