(29 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: 1. Slight X 4. Severe Configuration: ✓ 1. High Frequency - Precipitously Sloping
This air-conduction behind-the-ear hearing instrument, intended to amplify sound . pressure waves and transmit the signal to the external ear through the medium of air, is designed to compensate for hearing losses from mild to severe. The device is powered by a standard hearing aid battery (type 13). . The device is manufactured and delivered completely assembled to the hearing aid . dispenser using materials and techniques widely used by other manufacturers of hearing devices. The intended use, performance specifications, functions and operations of the . ReSound® Digital 2000-BT are essentially identical to that described in the 510(k) Premarket Notification for the ReSound® BT4 Personal Hearing System™ The predicate device has the ability to retain programs in memory, and, with the use of . the optional remote control, up to three programs are accessible. The ReSound® Digital 2000-BT, however, is remote control/programmer dependent, therefore, no programs are retained in the device if the device is turned off. The ReSound® Digital 2000-DP is programmed by the hearing health care professional with up to 4 different programs per ear via Noah based ReSound ReSource™ software. . The operation and functioning of the DAI option is identical to that offered by other hearing aid manufacturers.
The provided text does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding sample sizes, expert qualifications, or ground truth establishment.
Instead, the document is a 510(k) premarket notification letter from the FDA regarding the ReSound Digital 2000-BT hearing aid. It focuses on establishing substantial equivalence to a predicate device (ReSound BT4 Personal Hearing System™) based on design, intended use, performance specifications, and manufacturing.
Here's a breakdown of why the requested information isn't present:
- Acceptance Criteria and Reported Performance: The document outlines the functional similarities and differences between the new device and the predicate device, but it does not specify quantitative performance metrics or acceptance criteria for those metrics. For example, it mentions the device "is designed to compensate for hearing losses from mild to severe" but doesn't provide numerical thresholds for what constitutes "compensating."
- Study Details (Sample Size, Data Provenance, Experts, Adjudication): This type of detailed study information is typically found in clinical trial reports or performance evaluation summaries, which are not part of this 510(k) letter. The letter primarily focuses on regulatory approval based on equivalence.
- MRMC Comparative Effectiveness Study: There is no indication of a comparative effectiveness study involving human readers (or in this case, human users of hearing aids) with and without AI assistance.
- Standalone Performance: While the document describes the device's functionality, it doesn't present data from a standalone performance study in the way one might expect for an AI diagnostic device. The performance is implied to be similar to the predicate device.
- Ground Truth Type: For a hearing aid, "ground truth" would likely relate to objective measures of hearing improvement or speech intelligibility, but these are not detailed in this document.
- Training Set Sample Size and Ground Truth Establishment (for AI): Since this is a hearing aid and not an AI-driven diagnostic device in the modern sense (the "digital" refers to digital signal processing within the hearing aid, not a separate AI algorithm being trained on data), there's no mention of a training set or how ground truth for such a set would be established.
Summary based on the provided text:
The document focuses on demonstrating substantial equivalence to an existing predicate device rather than presenting a performance study with explicit acceptance criteria. Therefore, most of the requested information cannot be extracted from this text.
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Image /page/0/Picture/0 description: The image shows the logo for ReSound Hearing Health Care. The word "ReSound" is in a large, bold, italicized font, with the registered trademark symbol next to it. Below the word "ReSound" are the words "HEARING HEALTH CARE" in a smaller, non-italicized font.
K974257
DEC 12 1997
ReSound® Digital 2000-BT
SUMMARY OF SAFETY AND EFFECTIVENESS
Substantial equivalence for the ReSound® Digital 2000-BT to the predicate device, the ReSound® BT4 Personal Hearing System™, 510(k) No. K964557, November 27, 1996, is based on the following:
- This air-conduction behind-the-ear hearing instrument, intended to amplify sound . pressure waves and transmit the signal to the external ear through the medium of air, is designed to compensate for hearing losses from mild to severe.
- The device is powered by a standard hearing aid battery (type 13). .
- The device is manufactured and delivered completely assembled to the hearing aid . dispenser using materials and techniques widely used by other manufacturers of hearing devices.
- The intended use, performance specifications, functions and operations of the . ReSound® Digital 2000-BT are essentially identical to that described in the 510(k) Premarket Notification for the ReSound® BT4 Personal Hearing System™
- The predicate device has the ability to retain programs in memory, and, with the use of . the optional remote control, up to three programs are accessible. The ReSound® Digital 2000-BT, however, is remote control/programmer dependent, therefore, no programs are retained in the device if the device is turned off. The ReSound® Digital 2000-DP is programmed by the hearing health care professional with up to 4 different programs per ear via Noah based ReSound ReSource™ software.
- . The operation and functioning of the DAI option is identical to that offered by other hearing aid manufacturers.
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Image /page/1/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure, with three overlapping profiles suggesting a sense of community or interconnectedness. The profiles are rendered in a flowing, abstract manner. Encircling the figure is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 2 1997
Krista M. Buckles, M.A., CCC-A Principle Consultants clo Rocky Mountain Regulatory Consulting Resound® Hearing Health Care 220 Saginaw Drive Seaport Centre Redwood City, CA 94063
Re:
K974257 ReSound® Digital 2000-BT with ReSound® Digital 2000-DP (Digital Programmer) Dated: November 11, 1997 Received: November 13, 1997 Regulatory class: I 21 CFR 874.3300/Procode: 77ESD
Dear Ms. Buckles:
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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 incffective 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 notential 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,
Sincerely, Yin,
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): | K974257 | Page 1 of 1 | |||
|---|---|---|---|---|---|
| Device Name: | ReSound Digital 2000-BT |
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. __________ |
| X 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.)
(PLRAS 2 DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence (at CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K974257 |
Sescribted device (per 21 Cal 801.410 & 21 Caa 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.