SCIENTIFIC PLASTICS MODEL SP

K971299 · Scientific Plastics, Inc. · ESD · Jun 6, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K971299
• Device Name: SCIENTIFIC PLASTICS MODEL SP
• Applicant: Scientific Plastics, Inc.
• 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

Scientific Plastics Model SP ITC (In-The-Canal) hearing aid; air conduction device designed to amplify and transmit sound to the ear. Device features include volume control and integrated on/off switch. Powered by standard #312 hearing aid battery. Assembled from standard industry components. Frequency response customized based on individual client audiogram. Used by patients with hearing impairment to improve auditory perception.

Clinical Evidence

Bench testing only. Technical specifications obtained in accordance with S3.22-1987 ANSI Specifications.

Technological Characteristics

Air conduction hearing aid; ITC (In-The-Canal) form factor. Powered by #312 battery. Technical specifications comply with ANSI S3.22-1987. Manual volume control and on/off switch. No software or digital processing described.

Indications for Use

Indicated for individuals with impaired hearing, specifically those with slight, mild, or moderate hearing loss. Applicable to high frequency precipitously sloping, gradual sloping, reverse slope, and flat hearing loss configurations.

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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FEB 19 '97 04:25PM
P.2/13
JUN - 6 1997
K971299

# A SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

**Name of Device:** Scientific Plastics Model SP ITC Hearing Aid

**Type of Device:** Air Conduction Hearing Aid
**Intended Use:** To amplify and transmit sound to the ear.

**Features:** Volume Control. On/Off switch built into Volume Control.

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

**Technical Characteristics:** Technical specifications were obtained in accordance with S3.22-1987 ANSI Specifications. Preliminary data sheets for the SP models are enclosed.

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

**Power:** Standard hearing aid battery, #312

A user’s manual and other information is supplied with each hearing aid.

510(k) submission; page 2

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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

Jeffrey Stegman
Vice President
Scientific Plastics, Inc.
243 W. 30th Street
New York, NY 10001

Re: K971299
Scientific Plastics ITC Model SP
Dated: March 26, 1997
Received: April 7, 1997
Regulatory class: I
21 CFR 874.3300/Procode: 77 ESD

Dear Mr. Stegman:

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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FROM : Panasonic FAX SYSTEM
PHONE NO. : 2129679609
Jun. 03 1997 03:49PM P2

510(k) Number (if known): K971299

Device Name: Scientific Plastics Model SP ITC Hearing Aid

Indications For Use:

The indication for use of the air conduction hearing aid in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following categories:

Severity: Slight, Mild, Moderate

Configuration: High Frequency Precipitously Sloping, Gradual Sloping, Reverse Slope, Flat

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Restricted Device

Prescription Use ☐
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐
(Optional Format 1-2-96)

David G. Seymon
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K971299