(44 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 hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)): Severity: Mild, Moderate. Configuration: High Frequency - Precipitously Sloping, Gradually Sloping, Reverse Slope, Flat. Other: Low tolerance To Loudness.
The ReSound® Stealth CIC, a completely-in-the-canal hearing device, is an air-conduction hearing instrument, intended to amplify and transmit sound to the ear. The device is powered by a standard hearing aid battery (type 5A). The device is a completely in-the-canal one-channel device with K-Amp™ technology.
This document is a 510(k) premarket notification for the ReSound® Stealth CIC hearing device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with acceptance criteria for device performance. Therefore, many of the requested details about acceptance criteria and study particulars are not explicitly available or applicable in the provided text.
Here's an attempt to extract and infer the information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the format typically seen with clinical studies. Instead, it defines the device's characteristics and functionality and claims substantial equivalence to a predicate device (Philips XP CIC, 510(k) No. K921725). The "acceptance criteria" here are implicitly centered around these equivalence claims.
| Acceptance Criteria (Implied from Equivalence Claims) | Reported Device Performance (as stated in the document) |
|---|---|
| Effectiveness: Capable of amplifying and transmitting sound to the ear for hearing losses from mild to moderate up to 70 dB HL. | "The effectiveness of this air-conduction hearing instrument, intended to amplify and transmit sound to the ear, is equivalent to devices of the same type designed for hearing losses from mild to moderate up to 70 dB HL." (Claim of equivalence) |
| Power Source: Uses a standard hearing aid battery. | "The device is powered by a standard hearing aid battery (type 5A)." |
| Manufacturing/Delivery: Manufactured and delivered assembled using common materials and techniques. | "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." |
| Intended Use, Performance Specifications, Functions, Operations: Substantially equivalent to the predicate device. | "The intended use, performance specifications, functions and operations of the ReSound® Stealth CIC is substantially equivalent to the predicate device." (Claim of equivalence) |
| Device Type: Completely in-the-canal, one-channel, with K-Amp™ technology. | "The device is a completely in-the-canal one-channel device with K-Amp™ technology." |
| Safety: Maximum SSPL90 of less than 132 dB SPL, equivalent to devices of the same type. | "The safety of this device is equivalent to devices of the same type with maximum SSPL90 of less than 132 dB SPL." (Claim of equivalence) |
| Fitting Requirement: Requires deep canal impression. | "Proper fitting of this hearing aid (deep canal aid) requires the taking of a deep canal impression." (This is a user instruction, not a performance criterion per se, but part of safe use). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a specific "test set" for a clinical study with a sample size or data provenance. The basis for substantial equivalence is primarily through comparison to an existing predicate device and its known performance, along with specific design characteristics of the new device. No new clinical study data is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. As no new clinical test set was used to establish ground truth, no experts were involved in this capacity for the purpose of this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No new clinical test set was used, so no adjudication method was employed.
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
Not applicable. This device is a hearing aid, not an AI-assisted diagnostic tool for human readers. No MRMC study was conducted or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a hearing aid, which by its nature operates "with human-in-the-loop" (the wearer). There is no standalone algorithm performance that would be separated from human interaction in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this 510(k) submission, the "ground truth" for demonstrating substantial equivalence relies on:
- Performance specifications of the predicate device: The Philips XP CIC (K921725) sets the benchmark for performance, safety, and intended use as a legally marketed device.
- General understanding of hearing aid technology: The principles of amplification, power sources, manufacturing, and safety (e.g., maximum SSPL90) are established standards in the field.
- Engineering and design documentation: The internal data supporting the device's specifications (e.g., one-channel, K-Amp™ technology, battery type, SSPL90 levels) would have been used to demonstrate that it meets the expected performance characteristics comparable to the predicate.
8. The sample size for the training set
Not applicable. This submission does not describe a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set was used.
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K97408 DEC 1 2 1997
Image /page/0/Picture/1 description: The image shows the logo for ReSound Hearing Health Care. The word "ReSound" is in a large, bold, sans-serif font, with the registered trademark symbol next to the "D". Below "ReSound" is the phrase "HEARING HEALTH CARE" in a smaller, sans-serif font.
RESOUND® STEALTH CIC HEARING DEVICE
SUMMARY OF SAFETY AND EFFECTIVENESS
Substantial equivalence for the ReSound® Stealth CIC, a completely-in-the-canal hearing device, to the currently marketed predicate hearing device, the Philips XP CIC, 510(k) No. K921725, August 11, 1992, is based on the following:
- The effectiveness of this air-conduction hearing instrument, intended to amplify and transmit ● sound to the ear, is equivalent to devices of the same type designed for hearing losses from mild to moderate up to 70 dB HL.
- The device is powered by a standard hearing aid battery (type 5A). .
- 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® . Stealth CIC is substantially equivalent to the predicate device.
- The device is a completely in-the-canal one-channel device with K-Amp™ technology.
- The safety of this device is equivalent to devices of the same type with maximum SSPL90 of . less than 132 dB SPL.
- . Proper fitting of this hearing aid (deep canal aid) requires the taking of a deep canal impression. Hearing health professionals should not attempt this type of fitting unless they have developed the necessary skills to take this type of impression safely.
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Image /page/1/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized image of an eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 2 1997
Rocky Mountain Regulatory Consulting c/o Krista M. Buckles, M.A. CCC-A ReSound® Hearing Health Care 220 Saginaw Drive Seaport Centre Redwood City, CA 94063
Dear Ms. Buckles:
Re:
K974081 Resound® Stealth CIC Dated: October 17, 1997 Received: October 29, 1997 Regulatory class: I 21 CFR 874.3300/ 77 ESD
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 (OS) for Medical Devices: General regulation (2) 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 does not affect any obligation you might have under sections 531 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 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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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 Yin, 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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!
CDRE DRAERD
| 510(k) Number (if known): | K974087 | Page 1 of 1 |
|---|---|---|
| Device Name: | ReSound Stealth CIC | |
| 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 hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)):
| Severity: | Configuration: | Other |
|---|---|---|
| _1. Slight | X 1. High Frequency - Precipitously Sloping | X 1. Low tolerance To Loudness |
| X 2. Mild | X 2. Gradually Sloping | 2. |
| X 3. Moderate | X 3. Reverse Slope | 3. |
| _4. Severe | X 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.)
(PLEASE 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 | K974087 |
Reserieted device (per 21 Cara 801.410 & 21 Cra 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.