(88 days)
Not Found
No
The description focuses on standard hearing aid technology, digital programming, and memory for programs, with no mention of AI or ML capabilities. The comparison to a predicate device from 1990 further suggests the absence of modern AI/ML.
Yes
The device is described as an air conduction hearing aid intended to amplify sound for individuals with impaired hearing, which is a therapeutic purpose.
No
The device is a hearing aid, designed to amplify sound for individuals with impaired hearing, not to diagnose medical conditions.
No
The device description explicitly states it is a "behind-the-ear hearing instrument with body-worn processor" and is powered by batteries, indicating it is a hardware device with physical components, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The provided description clearly states that this device is an air conduction hearing aid. Its function is to amplify sound and transmit it to the external ear to compensate for hearing loss. It does not analyze any biological specimens.
- Intended Use: The intended use is to amplify sound for individuals with impaired hearing, not to diagnose or monitor a condition through the analysis of biological samples.
Therefore, based on the provided information, this device falls under the category of a hearing aid, which is a medical device but 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 the following category(ies). (Check appropriate space(s)): Severity: X 2. Mild X 3. Moderate X 4. Severe Configuration: X 1. High Frequency - Precipitously Sloping X 2. Gradually Sloping X 3. Reverse Slope X 4. Flat Other X 1. Low tolerance To Loudness 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
- This air-conduction behind-the-ear hearing instrument with body-worn processor is intended to . amolify 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 (type 13) and 2 standard alkaline type . AAA batteries.
- 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 Audallion® III . Hearing System 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 Audallion® III Hearing System has the ability to retain up to four programs in memory, iust as the predicate device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
JUN 17 1997
Audallion® III Hearing System
SUMMARY OF SAFETY AND EFFECTIVENESS
Substantial equivalence for the Audallion® III Hearing System 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 . amolify 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 (type 13) and 2 standard alkaline type . AAA batteries.
- 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 Audallion® III . Hearing System 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 Audallion® III Hearing System has the ability to retain up to four programs in memory, iust as the predicate device.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a circular seal for the Department of Health & Human Services USA. The seal features the department's logo, which is a stylized depiction of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the logo in a circular fashion.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 17 1997
Wayne E. Morris Director of Operations GN Danavox, Inc. 5600 Rowland Road, #250 ... Minnetonka, MN 55343
Re: K971031
Audallion® III Air Conduction Hearing Aid Dated: March 12, 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 beened substantially equivalent to other legally marketed hearing aids, please be advised that clectromagnetic 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 tenporarily 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
分
3
| 02/26/96 | 13:49 | 301 480 1224 | CDRH DRAERD | 002/ | |
|---|---|---|---|---|---|
| -- | ---------- | ------- | -------------- | ------------- | ------ |
Page 1 of 1
| 510(k) Number (if known): | _ |
|---|---|
| Device Name: | Audallion III Hearing System |
| 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)):
| Configuration: | Other | |
|---|---|---|
| Severity: | ||
| X 1. High Frequency - Precipitously Sloping | X 1. Low tolerance To Loudness | |
| 1. Slight | ||
| X 2. Mild | X 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)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
| 510(k) Number | K971031 |
|---|---|
| --------------- | --------- |
Restricted device (per 21 CFR 801.410 & 21 CFR 801.421)
はないとこしいと