(87 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).
Severity: Slight, Mild, Moderate, Severe, Profound
Configuration: 1. High Frequency - Precipitously Sloping, 2. Gradually Sloping, 3. Reverse Slope, 4. Flat
Other: Low tolerance To Loudness
The ITE, ITC, and CIC air conduction hearing aids are devices previously given marketing approval by the FDA. Beltone will be adding a new circuit option, GM-3036 manufactured by Gennum, to each of the models and will market this circuit option under the name CSP II Programmable.
The provided text describes a 510(k) premarket notification for Beltone Series CSP II Programmable Hearing Aids. This document is a regulatory submission for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with acceptance criteria for device performance.
Therefore, the information required to populate the table and answer the subsequent questions (acceptance criteria, specific study details, sample size, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types, and training set details) is not present within the provided text.
The document indicates that the technical characteristics comply with S3.22-1987 ANSI Standards, which would define certain performance acceptance criteria for hearing aids in general, but no specific study or reported performance against these standards is detailed. The FDA's letter explicitly states that "A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement..." and that "...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 further confirms that this is a regulatory approval document based on equivalence rather than detailed performance study results.
In summary, this submission relies on demonstrating that the new device (with a new circuit option) is substantially equivalent to previously approved hearing aids, rather than providing a detailed clinical study with specific acceptance criteria and performance data as might be found for a novel AI-driven diagnostic device.
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A SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
- AUG 1 5 1997 NAME OF DEVICE: Beltone Petite Plus K951587 Beltone Optima 2000 K9542213 Beltone Opera K940102 Beltone Invisa K940098 TYPE OF DEVICE: The ITE, ITC, devices are and CIC air aids given conduction hearing previously marketing approval by the FDA. Beltone will be adding a new circuit option, GM-3036 manufactured by Gennum, to each of the models and will market this circuit option under the name CSP II Programmable. INTENDED USE: To amplify and transmit sound to the ear FEATURES : Dispenser programmable features: Overall gain Low frequency gain High frequency gain Crossover frequency Compression threshold Maximum output ASSEMBLY : Assembled from standard components that are widely used by other hearing aid manufacturers TECHNICAL CHARACTERISTICS: Technical specifications comply with S3.22-1987 ANSI Standards FIT: Audiological characteristics
- dictated by individual audiogram
- CONTROLS : Volume control, switches, and optional dispenser operated trimmer controls similar to those of other devices
- POWER : Standard hearing aid battery
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 stylized human figure with three lines representing the head, body, and legs. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular pattern around the figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 15 1997
Robert A. Kratochvil Assistant to the VP of R&D Beltone Electronics Corporation 4201 W. Victoria Street Chicago, IL 60646
Re: K971852
Beltone Series CSP 11 Programmable Hearing Aids (Models: Invisa, Petite Plus, Opera Plus, Optima & Prima) Dated: May 19, 1997 Received: May 20, 1997 Regulatory class: I 21 CFR 874.3300/Procode: 77 ESD
Dear Mr. Kratochvil:
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 celielar 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 clectromagnetic 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 vitto 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,
Sincerely yours,
William Xi, 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 1 of 1
| 510(k) Number (if known): | K971852 | Page 1 of 1 | ||||
|---|---|---|---|---|---|---|
| Device Name: | INVISA CSPII-PPETITE PLUS CSPII-P | OPERA PLUS CSPII-POPTIMA PLUS CSPII-P | PRIMA 2000 CSPII-P | |||
| 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 | ||||
| ✔ Slight | ✔ 1. High Frequency - Precipitously Sloping | ✔ Low tolerance To Loudness | ||||
| ✔ Mild | ✔ 2. Gradually Sloping | 2. | ||||
| ✔ Moderate | ✔ 3. Reverse Slope | 3. | ||||
| ✔ Severe | ✔ 4. Flat | |||||
| ✔ 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. | ||||||
| (I LEASE 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, |
Division of Reproductive, Abdominal, ENT, and Radiological Device 1852 510(k) Number _
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.