NEW SOUND HIDDEN AID COMPLETELY IN CANAL (CIC)

K972039 · Nu-Sound · ESD · Aug 25, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K972039
• Device Name: NEW SOUND HIDDEN AID COMPLETELY IN CANAL (CIC)
• Applicant: Nu-Sound
• Product Code: ESD · Ear, Nose, Throat
• Decision Date: Aug 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3300
• Device Class: Class 1
• Attributes: Therapeutic

Indications for 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.

Device Story

Air conduction hearing aid; worn in ear canal (CIC) to amplify sound. Shell fabricated via light cure process; contains microphone, receiver, and integrated circuit. Powered by 1.5V DC disposable battery. Used by patients with hearing impairment; fitted by hearing professionals. Device amplifies ambient sound to assist with hearing loss; output delivered directly into ear canal. Potential for electromagnetic interference from digital cellular phones noted.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and intended use compared to existing legally marketed hearing aids.

Technological Characteristics

Air conduction hearing aid; CIC form factor. Shell constructed of light cure materials. Components: microphone, receiver, integrated circuit. Power: 1.5V DC disposable battery. No specific software algorithm class or connectivity specified.

Indications for Use

Indicated for individuals with slight to moderate (or severe, depending on model) hearing loss, including conductive, mixed, or sensori-neural types. Configurations include high frequency, gradually sloping, reverse slope, and flat. Contraindicated for perforated tympanic membrane or draining ear.

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.

Reference Devices

• Beltone (unspecified)
• Miracle Ear (unspecified)
• Siemens (unspecified)
• Oticon (unspecified)

Submission Summary (Full Text)

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K972039

## 510k SUMMARYs (L, K, L, K, L, K, L, L, L, L, L, L, L, L, L, L, L AUG 25 1997

Trade name: Hidden CIC Hearing Aid-

Common Name: CIC

Classification Name: Hearing Aid Class 1 (per 21 CFR Section 874.3300)

874.330: Air conduction hearing aid

Description: The device is an air conduction hearing aid. It is a prosthetic device worn in the ear canal to amplify sound. The shell is made using light cure materials and process. Various electronic components are utilized depending upon the type of circuitry needed.

Population: It is designed for individuals with a mild to moderately severe loss of hearing sensitivity that is either conductive, mixed, or sensori-neural in nature. Contraindications include perforated tympanic membrane or draining ear.

Technological Summary: The Hidden completely-in-the-canal (CIC) hearing aid designed by Nu-Sound is the same as Beltone, Miracle Ear, Siemens, and Oticon. Using a light cure process and materials, the shell is designed to fit into the external auditory meatus with the faceplate at or medial to the aperture and the receiver port terminating 1-2 mm beyond the osseocartilaginous juncture. The electronic components consist primarily of a microphone, receiver, and an integrated circuit. It depends upon the needs of the individual as to which circuit is incorporated into the shell. The power source is a 1.5 volt DC disposable battery.

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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 25 1997

Wava Brians Nu-Sound 2501 West Memorial Quail Spring Mall Oklahoma City, OK 73134

Re:

K972039 Nu Sound Hearing Aid, Models: Hidden L, Hidden K & Hidden C Dated: May 30, 1997 Received: June 2, 1997 Regulatory class: I 21 CFR 874.3300/Procode: 77 ESD

Dear Mr. Brians:

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 Federal 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 clectromagnetic 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,

Nillian Yi
Lillian Yiu, Ph.D.

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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Page / of 3

510(k Number (if known): K972039

Device Name NU-SOUND HEARING AND MID MODEL

Indications For Use:

A. General Indications:

The indication for use of the air conduction hearlng aids in this submission is to amplify sound for individuals with impaired The devices are indicated for individuals with losses in hoaring. the following category(ics). (Gnech appen-into RD2C8(5)):

Sevelly.

✓. Slight

✓. Mild

✓. Moderate

✓. Severe

-. Prosound

Configuration:

✓. High Frequency
- Precipitously Sloping

✓. Gradually Iloping

✓. Reverse Slope

✓. Flat

_ 5. Other

Other

✓ 1. Low tolerance
To Loudness

✓ 2. PEAK CLIPPING.

3.

R. Specific Indications (Only if appropriate.):
(MOK BOyanoacou. todiñazzione such as improved speech
intelligibility in Dackground was, must nupport44 snis-2
data.)

1.

2.

3.

CONTINUE ON ANOTHER PAGE IF NEEDEDI

(PLEASE DO NOT GRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF REEDEDS)

Concurrence of CDRH, Office of Device Evaluation (ODE)

I estricted device (per 21 CFR 801.420 6 21 CFR 801.421)

Arind G. beym
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K972039

t

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SIU(a Number (if Unnum):

Device Name: IU-Sound Hearing Aid Apsi K

Indications for Use:

n. General Indications:

The indication for use of the air conduction hearing adds in this submission is to amplify sound for individuals with impalred Submission is to anglity codicated for individuals with losses in nealing. The devices and Check appropriate space(s)):

| Severity: | Configuration: | Other |
|------------|-------------------------------------------|-----------------------------|
| ✓ Slight | 1. High Frequency - Precipitously Sloping | ✓ Low tolerance To Loudness |
| ✓ Mild | ✓ 2. Gradually Sloping | ✓ 2. Peak Cupping. |
| ✓ Moderate | ✓ 3. Reverse Slope | 3. |
| _ Severe | 4. Flat | |
| _ Prosound | 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)

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

Thish Segman
(Division Sign-Off)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number _ 5

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Page 2 of 3

| 510(k) Number (if known): | Hills-Sweeny Hearing Aid Model - L |
|---------------------------|------------------------------------|
|---------------------------|------------------------------------|

Indicutions For Usc:

A. General Indications:

The indication for use of the air conduction hearing aids in this submiseion is to amplify sound for individuals with impatred submission is to amplify sound for individuals with 10sses in
hearing. The devices are indicated for individuals with 10sses in
hearing. The devices (Check annoropriate space hearing. The devices are indicated for Includedably of the

| Severity: | | Configuration: | | Other |
|-------------------------------------------------------------|--|----------------------------------------------------------------------------------------------|--|------------------------------|
| <span style="text-decoration: underline;">✓</span> Slight | | <span style="text-decoration: underline;">✓</span> 1. High Frequency - Precipitously Sloping | | 1. Low tolerance To Loudness |
| <span style="text-decoration: underline;">✓</span> Mild | | <span style="text-decoration: underline;">✓</span> 2. Gradually Sloping | | 2. |
| <span style="text-decoration: underline;">✓</span> Moderate | | <span style="text-decoration: underline;">✓</span> 3. Reverse Slope | | 3. |
| <span style="text-decoration: underline;">✓</span> Severe | | <span style="text-decoration: underline;">✓</span> 4. Flat | | |
| - Protound | | 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)

I estricted device (per 21 CER 801-420 & 21 CFR 801.421)

Thail C. Segmen

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number