(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: Slight, Mild, Moderate, Severe
Configuration: High Frequency Precipitously Sloping, Gradually Sloping, Reverse Slope, Flat, Other ski-sloping
Other: Low tolerance to Loudness, Compression Limiting, Loudness Growth Compensation
CIC, ITE and BTE Hearing Aids
The provided document describes a 510(k) submission for the "Miracle-Ear Programmable Sharp Dynamic Hearing Aids". However, it is a notification of intent to market a device and focuses on establishing substantial equivalence to a predicate device, rather than providing a detailed study that proves the device meets specific acceptance criteria through performance data.
Therefore, many of the requested items cannot be fully extracted from this document because it does not contain a study report with performance metrics, ground truth establishment, or sample sizes related to clinical validation.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states that "Dahlberg utilizes the ANSI S3.22-1987 methodology to test and obtain performance data for hearing aids." This implies that the acceptance criteria are likely derived from or comply with the standards set forth in ANSI S3.22-1987. However, the specific acceptance criteria (e.g., maximum output, frequency response characteristics, total harmonic distortion limits) and the reported device performance against those criteria are not provided in this document. The table in Appendix B only lists technical characteristics and fit details, not specific performance metrics.
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not specified in the provided document. The 510(k) summary focuses on substantial equivalence rather than a detailed clinical trial's test set.
- Data Provenance: Not specified in the provided document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method for the test set:
- Adjudication Method: Not specified.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: Not applicable. This device is a hearing aid, not an AI-assisted diagnostic tool that would involve human "readers" or AI-driven improvements in diagnostic accuracy.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable in the context of AI algorithms. This refers to the standalone performance of the hearing aid itself, which would be assessed against ANSI standards. The document states that the ANSI S3.22-1987 methodology is used to test performance, implying a standalone assessment of the device's electroacoustic characteristics. However, the results of this standalone testing are not provided.
7. The type of ground truth used:
- Type of Ground Truth: For hearing aids, "ground truth" typically refers to objective electroacoustic measurements against established performance standards (such as ANSI S3.22-1987). It also involves fitting parameters based on an individual's audiogram. Clinical efficacy might be assessed through user perception and audiological benefits, but comprehensive "ground truth" like pathology or outcomes data in the AI diagnostic sense is not relevant here. The clinical indications for use are based on the amplification of sound for individuals with impaired hearing, linked to audiogram severity and configuration (e.g., slight to severe hearing loss, high frequency sloping, gradually sloping, etc.).
8. The sample size for the training set:
- Sample Size (Training Set): Not applicable in the context of machine learning. This device does not appear to be an AI/ML driven device that requires a "training set."
9. How the ground truth for the training set was established:
- Ground Truth Establishment (Training Set): Not applicable, as there is no indication of an AI/ML training set.
Summary based on the document:
The document is a 510(k) premarket notification for a hearing aid, seeking substantial equivalence to a predicate device. It explicitly states that the device utilizes the ANSI S3.22-1987 methodology for performance testing. This standard would define the acceptance criteria and the methods for obtaining performance data. However, the actual performance data against these criteria is not included in this summary. The "Indications For Use" (Page 3) specify the types and severities of hearing loss the device is intended to address, but these are indications, not performance metrics or acceptance criteria per se.
In essence, the document serves as a regulatory clearance document based on substantial equivalence, rather than a detailed scientific study report demonstrating the device's performance against specific acceptance criteria.
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Appendix B
JUL 2 3 1997
Summary of Safety and Effectiveness
| Device Name: | Miracle-Ear Programmable Sharp Dynamic Hearing Aids |
|---|---|
| Device Type: | CIC, ITE and BTE Hearing Aids |
| Classification: | Air Conduction Hearing Aid (77ESD), Class I. |
| Intended Use: | To amplify and transmit sound to the ear. |
| Substantially Equivalent to: | Dahlberg multi-channel compression aids which were cleared fordistribution under 510(k) # K960804. |
| Registration Number: | 2110592 |
| Materials: | The hearing aid shells will be manufactured frommaterials that are commonly used in the industry. |
| Technical Characteristics: | Dahlberg utilizes the ANSI S3.22-1987 methodology totest and obtain performance data for hearing aids. |
| Fit: | Mild to severe as dictated by the individual usersaudiogram. |
| Power: | Various sizes of Zinc-Air hearing aid batteries. |
分彩
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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 eagle with three lines forming its body and wings. The eagle is enclosed in a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Melanie Raska Manager of Regulatory Affairs ... . . . . Dahlberg, Inc. 4101 Dahlberg Drive Golden Valley, MN 55422
Re: K972345 Miracle-Ear Programmable Sharp .......... Dynamic Air Conduction Hearing Aids Dated: June 23, 1997 Received: June 24, 1997 Regulatory Class: I 21 CFR 874.3300/Procode: 77 ESD
Dear Ms. Raska:
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 Eederal 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 collular 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 incifective 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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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 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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Page __ 1 of 1___
510(k) Number (if known): _|<972345
Device Name: Miracle-Ear Programmable Sharp Dynamic 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)):
| Severity: | Configuration: | Other: |
|---|---|---|
| ✓ 1. Slight | ✓ 1. High FrequencyPrecipitously Sloping | ✓ 1. Low toleranceto Loudness |
| ✓ 2. Mild | ✓ 2. Gradually Sloping | ✓ 2. Compression Limiting |
| ✓ 3. Moderate | ✓ 3. Reverse Slope | ✓ 3. Loudness GrowthCompensation |
| ✓ 4. Severe | ✓ 4. Flat | |
| __ 5. Profound | ✓ 5. Other ski-sloping |
- Specific Indications (Only if appropriate): B. (Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data).
(Division Sign-Off)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number 1972.345
Restricted Device Per 874.420 and 421
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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.