(44 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the device description focuses on traditional hearing aid technology (K-Amp™).
No.
The device is a hearing aid, which amplifies sound for individuals with impaired hearing. While it improves quality of life, it does not treat or cure a disease, which is typically the characteristic of a therapeutic device.
No
A diagnostic device identifies a disease or condition. This device is a hearing aid, designed to amplify sound for individuals with impaired hearing, which is a treatment or a compensatory device, not a diagnostic one.
No
The device description explicitly states it is a "completely-in-the-canal hearing device" and is "powered by a standard hearing aid battery," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is an "air-conduction hearing instrument, intended to amplify and transmit sound to the ear." It works by processing sound from the environment and delivering it to the user's ear.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing any biological samples from the patient. Its function is purely related to sound amplification and transmission.
Therefore, this device falls under the category of a medical device, specifically a hearing aid, and not an in vitro diagnostic device.
N/A
Intended Use / 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.)
Product codes (comma separated list FDA assigned to the subject device)
77 ESD
Device Description
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hearing aid dispenser, Hearing health professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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.
2
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
3
!
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)