← Product Code [ESD](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD) · K971807
# IN THE EAR, IN THE CANAL, COMPLETELY IN THE CANAL (K971807)
_Hear-Right, Inc. · ESD · Aug 7, 1997 · Ear, Nose, Throat · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K971807
## Device Facts
- **Applicant:** Hear-Right, Inc.
- **Product Code:** [ESD](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD.md)
- **Decision Date:** Aug 7, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.3300
- **Device Class:** Class 1
- **Review Panel:** Ear, Nose, Throat
- **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).
## Device Story
Hear-Right hearing aids (CIC, ITC, ITE models) function as air conduction hearing aids to amplify sound for hearing-impaired individuals. Devices capture ambient sound via microphone, process signal through internal circuitry (K-Amp programmable or linear), and deliver amplified output to the ear canal. Used in daily life by patients; fitted by hearing healthcare professionals. Output provides auditory assistance to improve patient communication and environmental awareness. Potential for electromagnetic interference from digital cellular phones noted; labeling advises caution.
## Clinical Evidence
No clinical data provided. The document indicates that psychoacoustic claims, such as improved speech intelligibility in background noise, require supporting clinical data, which was not included in this submission.
## Technological Characteristics
Air conduction hearing aids; models include Hidden CIC, Cardinal ITC, and Eagle ITE. Features K-Amp programmable or linear circuitry. Class I device (21 CFR 874.3300).
## Regulatory 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 7 1997
Craig Bloomingburg¨¨ President Hear-Right, Inc. 2606 Villa Prom Suite 74 Oklahoma City, OK 73107 Re: K971807 ·
Hear-Right Hearing Aidsl; Models: Hidden CIC (HP, HL, HK, H JC), Cardinal ITC (CP, CL. CK) Eagle ITE (EP, EL, EK, EB) Dated: May 8, 1997 Received: May 15, 1997 Regulatory class: I 21 CFR 874.3300/Procode: 77 ESD
Dear Mr. Bloomingham:
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 decined substantially cquivalent to cities 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 clectromagnetic 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 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,
Nillian Yhi
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): | K97/807 | Page 1 of 11 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Device Name: | Hidden CIC K-Amp Programmable (HP) | |
| 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. __________ |
| 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. __________ | |
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)