(88 days)
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:
X 1. Slight
X 2. Mild
X 3. Moderate
X 4. Severe
Configuration:
X 1. High Frequency - Precipitously Sloping
X 2. Gradually Sloping
X 3. Reverse Slope
X 4. Flat
Other
X 1. Low tolerance To Loudness
To amplify and transmit sound to the ear.
Assembled from standard components which are widely utilized by other hearing aid manufacturers.
The frequency response of this product is dictated by the individual audiogram from each client.
Standard hearing aid battery.
A user's manual and other information is supplied with each hearing aid.
The provided text does not contain any information about acceptance criteria, device performance results from a study, or details of a study methodology.
The document is a US FDA 510(k) clearance letter for Heartland Technologies' ITE, ITC, and CIC hearing aids, dated August 15, 1997. It declares the device "substantially equivalent" to legally marketed predicate devices, allowing its commercialization.
The letter mentions:
- Intended Use: "To amplify and transmit sound to the ear."
- Technical Characteristics: "Technical specifications were obtained in accordance with S3.22-1987 ANSI Specifications."
- Fit: "The frequency response of this product is dictated by the individual audiogram from each client."
- Indications for Use: General indications for individuals with impaired hearing across various severity levels (slight, mild, moderate, severe), configurations (high frequency - precipitously sloping, gradually sloping, reverse slope, flat), and "Low tolerance To Loudness."
Therefore, I cannot provide the requested information regarding acceptance criteria and study details because it is not present in the provided text. The letter primarily focuses on regulatory clearance based on substantial equivalence, not on the detailed results of a performance study against specific acceptance criteria.
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A SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
| Name of Device: | HEARTLAND TECHNOLOGIES |
|---|---|
| Type of Device: | ITE, ITC, CIC HEARING AIDS |
| Intended Use: | To amplify and transmit sound to the ear. |
| AUG 15 1997 | |
| Features: | SEE ATTACHED SPECIFICATION SHEET |
| Assembly: | Assembled from standard components which are widely utilized by other hearing aid manufacturers. |
| TechnicalCharacteristics: | Technical specifications were obtained in accordance with S3.22-1987ANSI Specifications.Preliminary data sheets for the ITE, ITC, CIC models are enclosed. |
| Fit: | The frequency response of this product is dictated by the individual audiogram from each client. |
- Standard hearing aid battery, . Power:
A user's manual and other information is supplied with each hearing aid.
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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" arranged around the perimeter. Inside the circle is an abstract symbol that resembles three human figures or stylized birds in flight. The symbol is composed of curved lines and is positioned in the center of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 5 1997
Dale Woodard President Sound Hearing Instruments 4808 Nicollet Ave. South Minneapolis, MN 55409
Re: K971845 Heartland Technologies ITE, ITC, and CIC Hearing Aids Dated: May 16, 1997 Received: May 19, 1997 Regulatory Class: I 21 CFR 874.3300/Procode: 77ESD
Dear Mr. Woodard:
We have reviewed your Section 510(k) notification of intent to market the device 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 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 equivatent 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 clectromagnetic interference may affect your device, you may be asked to test for electronizagnetic 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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Page 2
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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597.or at its ... Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
William Yih
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): | K971845 | Page of |
|---|---|---|
| --------------------------- | --------- | --------- |
Devive Name: HEARTLAND TECHNOLOGIES -ITE, ITC, CIC HEARING AIDS
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)):
| Sever ty: | Configuration: | Other |
|---|---|---|
| X 1. Slight | X 1. High Frequency - Precipitously Sloping | X 1. Low tolerance To Loudness |
| X 2. Mild | X 2. Gradually Sloping | 2. |
| X 3. Moderate | X 3. Reverse Slope | 3. |
| X 4. Severe | X 4. Flat | |
| 5. 'rofound | 5. Other |
- Specific Indications (Only if appropriate.):
(Most psychoacoustic indications such as improved speech
Antelligibility in background noise, must be supported by clinical
data.)
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K971845
Restricted device (per 21 CFR 801.420 & 21 CFR 801.421)
§ 874.3300 Air-conduction hearing aid.
(a)
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.(b)
Classification. Class I (general controls). This device is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 874.9.