(21 days)
A. General: 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 catage(fes). (Check appropriate space(s)): Severity: Mild, Moderate. Configuration: Flat.
B. Specific (List Claims): Not Found
AIR CONDUCTION HEARING AID (BC-H2000)
This document is a 510(k) premarket notification decision letter from the FDA for an Air Conduction Hearing Aid (Model PC-H2000). It primarily addresses the device's substantial equivalence to existing devices and provides regulatory guidance. As such, it does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria in the format requested.
Specifically, the document lacks:
- A table of acceptance criteria and reported device performance.
- Information on sample sizes for test and training sets, data provenance.
- Details on expert involvement for ground truth establishment.
- Adjudication methods.
- Comparisons to human readers (MRMC study).
- Standalone algorithm performance.
- Types of ground truth used.
- How ground truth for the training set was established.
The document only states the "Indications For Use" for the hearing aid, which includes amplifying sound for individuals with impaired hearing, specifically for "mild" and "moderate" severity losses and a "flat" configuration. These are indications for use, not quantitative acceptance criteria with performance metrics.
The letter mentions that "Most psycho/acoustic claims, including those pertaining to the understanding of speech in noise, must be supported by clinical data," suggesting that such data would typically be part of a submission for those claims, but this document does not contain that data or its analysis.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 29 1997
Re:
Phillip Rechister Baron Tranding, Inc. 22305 Dunmore Dr. Calabasas, CA 91302
K973846 Air Conduction Hearing Aid (Model PC-H2000) Dated: September 10, 1997 Received: October 8, 1997 Regulatory class: I 21 CFR 874.3300/Procode: 77 ESD
Dear Mr. Rechister:
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 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 annoving 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 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,
llian Yi
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 of
5 i 0(k) Number (if known): $973840
Device Name: AIR CONDUCTION HEARING AID (BC-H2000
Indications For Use:
A. General:
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 catage (fes). (Check appropriate space(s)):
| Severity: | |
|---|---|
| __ 1. Slight | |
| ✓2. Mild | |
| ✓✓3. Moderate | |
| __ 4. Severe | |
| __ 5. Profound |
| Configuration: | |
|---|---|
| __ 1. High Frequency - Precipitously Sloping | |
| __ 2. Gradually Sloping | |
| __ 3. Reverse Slope | |
| ✓4. Flat | |
| __ 5. Other |
| Other | |
|---|---|
| __ 1. Low tolerance To Loudness | |
| __ 2. | |
| __ 3. |
B. Specific (List Claims):
(Most psycho/acoustic claims, including those pertaining to the understanding of speech in noise, must be supported by clinical data.)
(PLIASE 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: K973846
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.