(21 days)
Not Found
None
No
The provided text focuses on the intended use and indications for a hearing aid, describing its function as sound amplification for individuals with impaired hearing. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is a hearing aid, which is used to amplify sound for individuals with impaired hearing, directly addressing a health condition.
No
The text states that the device's indication for use is "to amplify sound for individuals with impaired hearing." This describes a therapeutic function, not a diagnostic one.
No
The description focuses on air conduction hearing aids, which are hardware devices that amplify sound. There is no mention of software being the primary or sole component of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided text describes a device that amplifies sound for individuals with impaired hearing. This is a hearing aid.
- Intended Use: The intended use is to amplify sound and deliver it to the ear via air conduction. This is a physical function related to hearing, not a diagnostic test performed on a biological sample.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of biomarkers, or diagnostic purposes related to disease or condition identification through in vitro methods.
Therefore, based on the provided information, this device is a hearing aid and not an In Vitro Diagnostic.
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 the following category(ies). (Check appropriate space(s)):
| Severity: | |
|---|---|
| 1. Slight | ✓ |
| 2. Mild | ✓ |
| 3. Moderate | ✓ |
| 4. Severe | |
| 5. Profound |
| Configuration: | |
|---|---|
| 1. High Frequency - Precipitously Sloping | ✓ |
| 2. Gradually Sloping | ✓ |
| 3. Reverse Slope | |
| 4. Flat | ✓ |
| 5. Other |
| Other | |
|---|---|
| 1. Low tolerance To Loudness | ✓ |
| 2. | |
| 3. |
B. Specific Indications (Only if appropriate.):
- To amplify and deliver sound to the ear via air conduction
Product codes
77 ESD
Device Description
Not Found
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
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol of medicine and health. The caduceus is depicted as a staff with two snakes entwined around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 4 1997
Proben Brunved Oticon, Inc. 29 Schoolhouse Rd. Somerset, NJ 08873 Re:
K973885 Oticon DigiSound ITE Hearing Aid Dated: October 10, 1997 Received: October 14, 1997 Regulatory class: I 21 CFR 874.3300/Procode: 77 ESD
Dear Mr. Brunved:
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 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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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,
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
2
page / of /
510(k) Number (if known):
116 Device Name
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: | |
|---|---|
| 1. Slight | ✓ |
| 2. Mild | ✓ |
| 3. Moderate | ✓ |
| 4. Severe | |
| 5. Profound |
| Configuration: | |
|---|---|
| 1. High Frequency - Precipitously Sloping | ✓ |
| 2. Gradually Sloping | ✓ |
| 3. Reverse Slope | |
| 4. Flat | ✓ |
| 5. Other |
| Other | |
|---|---|
| 1. Low tolerance To Loudness | ✓ |
| 2. | |
| 3. |
B. Specific Indications (Only if appropriate.): (Most psychoacoustic indications such as improved speech intelligibility in background noise. must be supported by clinical data.)
-
To amplify and deliver sound to the ear via air conduction
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF HEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Yhird le. Sezemm
(Division Sign Off)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological D 510(k) Number
Restricted device (per 21 CFR 801.420 & 21 CFR 801.421)