VISTA V-38 CIC

K970939 · Vista Labs · ESD · Jun 6, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K970939
• Device Name: VISTA V-38 CIC
• Applicant: Vista Labs
• Product Code: ESD · Ear, Nose, Throat
• Decision Date: Jun 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3300
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

To amplify and transmit sound to the ear.

Device Story

Vista V-38 CIC is an air conduction hearing aid designed to fit completely within the ear canal. Device reduces residual ear canal volume, decreasing occlusion effect and feedback while improving high-frequency gain. Input is ambient sound; device amplifies and transmits sound to the ear. Circuits include Class D, K-amp, and RGA Class A configurations. Volume is adjusted via a standard screw-set control. Powered by #10A or 5A battery. Frequency response is customized based on individual client audiograms. Used by hearing-impaired individuals; fitted by hearing healthcare professionals. Benefits include improved sound perception and reduced self-masking.

Clinical Evidence

No clinical data provided; bench testing only. Technical specifications comply with ANSI S3.22-1987.

Technological Characteristics

Air conduction hearing aid; CIC form factor. Circuits: Class D, K-amp, RGA Class A. Power: #10A or 5A battery. Controls: Screw-set volume control. Compliance: ANSI S3.22-1987.

Indications for Use

Indicated for individuals with impaired hearing, specifically slight to severe hearing loss, including high frequency, precipitously sloping, or flat 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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6-06-1997 11:13AM FROM P. 3
K970939 JUN - 6 1997

# A SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

Name: Vista Labs 409 S. Tower, Centralia, WA 98531
Owner: James E. Pannette
Establishment Registration Number: 3025260
510(k) Number: K970939

Name of Device: Vista Completely In The Canal (CIC) V-38 Hearing Aid

Type of Device: In the Canal Air Conduction Hearing Aid - Substantially equivalent to other In the Canal Air Conduction hearing aids.

Intended Use: To amplify and transmit sound to the ear.

Features: The Vista completely in the canal (CIC) is a small instrument designed to fit competely in the ear canal. The volume control is a standard screw-set control and uses a #10A or 5A battery. The CIC fit reduces residual ear canal volume and results in the need for less gain, decreased chance of feedback, improvement of high frequency gain, decreased occlusion effect, and lesser self-masking. The CIC's circuits are assembled into a variety of different configurations including Class D, K-amp, and RGA Class A.

Assembly: Assembled from standard components which are widely utilized by other hearing aid manufacturers.

Technical Characteristics: Technical specifications comply with S3.22-1987 ANSI Specifications. Preliminary data sheets from the CIC V-38 models are enclosed.

Controls: Dispenser controlled Volume Control.

Fit: The frequency response of this product is dictated by the individual audiogram from each client.

Power: Standard hearing aid battery.

A user's manual and other information is supplied with each hearing aid (enclosed).

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUN - 6 1997

Randy L. Bishop
Director of Audiology
Vista Labs
409 South Tower
Centralia, WA 98531

Re: K970939
VISTA V-38 CIC Hearing Aid
Dated: February 17, 1997
Received: March 13, 1997
Regulatory Class: I
21 CFR 874.3300/Procode: 77 ESD

Dear Mr. Bishop:

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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24 '97 02:43PM
P.3/4

510 (k) Number (if known): K970939

Device Name: Vista V-38 CIC

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
2. ☑ Mild
3. ☑ Moderate
4. ☑ Severe
5. ☐ Profound | 1. ☑ High Frequency
Precipitously Sloping
2. ☐ Gradually Sloping
3. ☐ Reverse Slope
4. ☑ Flat
5. ☐ Other | 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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