(90 days)
Not Found
No
The summary describes a system for fitting and programming hearing aids based on patient data, but there is no mention of AI or ML being used in the process. The description focuses on data storage and parameter setting.
No.
The device is used for fitting and programming hearing aids, not for treating a condition directly. It acts as a tool for managing a therapeutic device (hearing aid) rather than being a therapeutic device itself.
No
The device is described as a "fitting and programming system" for hearing aids. Its functions include fitting, programming, and storing patient data (audiogram, loudness information, etc.), which are related to adjusting and managing a treatment device (hearing aid) rather than diagnosing a medical condition. While it uses patient audiogram and loudness data, it doesn't diagnose a hearing impairment; it uses pre-existing diagnostic data to configure a device.
No
The device description explicitly states it is a "hand-held, battery-powered, portable device," indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for fitting and programming hearing aids based on patient audiogram and loudness data. This is a process related to hearing correction and device configuration, not the diagnosis of a disease or condition using in vitro methods (testing samples like blood, urine, etc.).
- Device Description: The description reinforces its function as a tool for fitting and programming hearing aids and storing patient data.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information about a patient's health status through in vitro testing.
The device is clearly intended for use in the context of hearing aid dispensing and fitting, which falls under the category of medical devices used for treatment or management of hearing loss, not in vitro diagnosis.
N/A
Intended Use / Indications for Use
The Sonix Hearing Aid Fitting and Programming System is a lightweight hand-held batterypowered device intended for use in fitting and programming Sonix hearing aids using individual patient audiogram and/or loudness data. It also provides database storage of patient identification information, audiogram, loudness information and hearing aid selection and fitting parameters.
Product codes
77 ESD
Device Description
The Sonix Hearing Aid Fitting and Programming System is a hand-held, battery-powered, portable device used to fit and program Sonix hearing aids and to store certain patient data.
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)
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
SUMMARY OF SAFETY AND EFFECTIVENESS
JAN | Z 1000
The Sonix Hearing Aid Fitting and Programming System is a hand-held, battery-powered, portable device used to fit and program Sonix hearing aids and to store certain patient data. The Sonix Hearing Aid Fitting and Programming System is substantially equivalent to the microfit®/microtouch™ programming system by Micro-Tech [510(k) No. unknown} and the ReSound Portable Prescriptive Programming System@[510(k) No. K931372. Substantial equivalence to the predicate devices, is based on the following:
- The intended use is the same, i.e., the Sonix Hearing Aid Fitting and Programming System is . a lightweight hand-held device intended to fit and program Sonix hearing aids. It also provides database storage of patient identification and audiologic information.
- The device is lightweight and fully portable. ●
- . Standard batteries power the device.
- . The microcomputer base meets FCC and CE-Marking requirements.
- The System displays the frequency response, gain and output characteristics of the hearing . aid type being programmed.
- . No software installation is required on the part of the dispenser.
- . The level of concern for the software is MINOR.
- . The Sonix Hearing Aid Fitting and Programming System does not raise new issues of safety or effectiveness.
In conclusion, the Sonix Hearing Aid Fitting and Programming system described in this submission is substantially equivalent, i.e., has the SAME intended use and does not raise different questions regarding safety and effectiveness, to the Micro-Tech microfit@fmicrotouch™. programming system and the ReSound Portable Prescriptive Programming System@[510(k) No. K931372].
J. S. Johnson Sonix Technologies, Inc.
2 Schill
CONFIDENTIAL
1
Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN | 2 |998
Jeannette Seloover Johnson, Ph.D. Vice President, Research and Planninig Sonix Technologies, Inc. 5330 South 900 East, Suite 240 Salt Lake City, Utah 84117-7261
Re:
K973880 Sonix Hearing Aid Fitting and Programming System Dated: October 13, 1997 Received: October 14, 1997 Regulatory class: I 21 CFR 874.3300/Procode: 77 ESD
Dear Dr. Johnson:
We have reviewed your Section 510(k) notification of intent to marker the device referenced above and we have determined the device is substantially equivalent for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 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 (21 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 submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under 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 marked predicate device results in a classification for your device and thus, permits your device to proceed to the market. . . . . . . . . . .
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 question 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,
Sincerely yours,
Lillian 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
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| Page | _________ of _________ |
|---|---|
| ------ | ------------------------ |
510(k) Number (if known): _ K973889 __________________________________________________________________________________________________________________________________________
Device Name: THE SCNIX HEARING AID FITTING A PROGRAMMING 5 YSTEM
Indications For Use:
The Sonix Hearing Aid Fitting and Programming System is a lightweight hand-held batterypowered device intended for use in fitting and programming Sonix hearing aids using individual patient audiogram and/or loudness data. It also provides database storage of patient identification information, audiogram, loudness information and hearing aid selection and fitting parameters.
(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 | K973880 |
| Prescription Use | OR | Over-The-Counter Use |
|---|---|---|
| ------------------ | ---- | ---------------------- |
(Per 21 CFR 801.109)
OR
Over-I he-Counter Use
(Optional Format 1-2-96)