(88 days)
Not Found
Based on the provided text, there is no mention of an AI model being used in the air conduction hearing aids. The text focuses on the intended use and indications for use of the devices, which is to amplify sound for individuals with impaired hearing.
Therefore, based solely on the provided text, this device does not contain an AI model.
Yes
The device is described as an "air conduction hearing aid" intended to "amplify sound for individuals with impaired hearing." This function directly addresses and mitigates a health impairment (impaired hearing), classifying it as a therapeutic device.
No
The document states that the device's indication for use is to amplify sound for individuals with impaired hearing, not to diagnose hearing impairment.
No
The summary describes "air conduction hearing aids," which are hardware devices that amplify sound. While they may contain software for processing, the core device is a physical hearing aid, not software-only.
Based on the information provided, the device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: An In Vitro Diagnostic (IVD) device is a medical device used to perform tests on samples such as blood, urine, or tissues to detect diseases, conditions, or infections. These tests are performed outside the body (in vitro).
- Hearing Aid Function: The description states the device is an "air conduction hearing aid" and its intended use is to "amplify sound for individuals with impaired hearing."
- Mechanism of Action: Hearing aids work by amplifying sound waves and delivering them to the ear. This is a physical process that happens in vivo (within the body), specifically within the ear canal and middle/inner ear. They do not perform tests on biological samples.
Therefore, a hearing aid, based on this description, is a medical device but it does not fit the definition of an In Vitro Diagnostic device. It is a device that aids hearing by modifying sound, not by analyzing biological samples.
N/A
Intended Use / Indications for Use
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.
Severity:
X 2. Mild
X 3. Moderate
X 4. Severe
Configuration:
X 1. High Frequency - Precipitously Sloping
X 3. Reverse Slope
X 4. Flat
Other:
X 1. Low tolerance To Loudness
Product codes (comma separated list FDA assigned to the subject device)
77 ESD
Device Description
This air-conduction behind-the-ear hearing instrument with body-worn processor is intended to amplify sound pressure waves and transmit the signal to the external ear through the medium of air to compensate for hearing losses from mild to severe.
The device is powered by a standard hearing aid battery (Model 163 type 13 , Model 162 -● type 312).
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 Danavox 163 / 162 BTE are essentially identical to that described in the 510(k) Premarket Notification for the Danavox Aura.
The ability to program digitally the fitting parameters of the hearing device is the same as in the Danavox Aura as is the ability to change the characteristics of the sound processing and adjust the volume.
The Danavox 163 / 162 BTE has the ability to retain up to three programs in memory, whereas the predicate device can retain four programs in memory.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear / external ear
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hearing aid dispenser
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
Image /page/0/Picture/0 description: The image shows the word "DANAVOX" in large, bold, black letters. Below the word, in smaller letters, is the phrase "Partners in Hearing Care". The text is centered and the font is a serif typeface.
JUN | 7 1997
Danavox 163 / 162 BTE
SUMMARY OF SAFETY AND EFFECTIVENESS
Substantial equivalence for the Danavox 163 / 162 BTE to the predicate device, the Danavox Aura 510(k) No. K905692 is based on the following:
- This air-conduction behind-the-ear hearing instrument with body-worn processor is intended to . amplify sound pressure waves and transmit the signal to the external ear through the medium of air to compensate for hearing losses from mild to severe.
- The device is powered by a standard hearing aid battery (Model 163 type 13 , Model 162 -● type 312) .
- 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 Danavox 163 / 162 ● BTE are essentially identical to that described in the 510(k) Premarket Notification for the Danavox Aura.
- The ability to program digitally the fitting parameters of the hearing device is the same as in the ● Danavox Aura as is the ability to change the characteristics of the sound processing and adjust the volume.
- The Danavox 163 / 162 BTE has the ability to retain up to three programs in memory, whereas ● the predicate device can retain four programs in memory.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
JUN 17 1997
Mr. Wayne Morris Director of Operations GN Danavox, Inc. 5600 Rowland Road, #250 Minnetonka, MN 55343
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K971032
DANAVOX Model 163/162 BTE Hearing Aids Dated: March 20, 1997 Received: March 21, 1997 Regulatory Class: I 21 CFR 874.3300/Procode: 77 ESD
Dear Mr. Morris:
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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 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
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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 at (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
3
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Danavox Model 163/162 BTE Device Name:_
Indications For Use:
a. General Indications:
The indication for use of the air conduction hearing aius in this The indication for use of the arr condividuals with impaired submission is to amplity sound tor individuals with losses in
hearing. The devices are indicated for individuals with losses in
thearing. The devices are indicated for indivi hearing. The devices are indicated books. In the space(s)):
| Severity: | Configuration: | Other |
|---|---|---|
| 1. Slight | X 1. High Frequency - Precipitously Sloping | X 1. Low tolerance To Loudness |
| X 2. Mild | 2. Gradually Sloping | 2. |
| X 3. Moderate | X 3. Reverse Slope | 3. |
| X 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)
David A. Segman
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
| 510(k) Number | K971032 |
|---|---|
| --------------- | --------- |
Restricted device (per 21 CFR 801.420 & 21 CFR 801.421)