(46 days)
Not Found
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on traditional FM system technology for sound amplification and signal-to-noise ratio improvement.
Yes
The device is intended to amplify sound for individuals with impaired hearing, which is a therapeutic function addressing a medical condition (hearing loss and related conditions).
No.
The device's sole purpose is to amplify sound for individuals with impaired hearing, focusing on improving the signal-to-noise ratio. It does not perform any diagnostic function to identify or assess the nature of hearing loss or other conditions.
No
The device description explicitly names "HEARING HELPER PERSONAL FM SYSTEM Models PFM300 & PFM 358" and "WILLIAMS SOUND, HEARING HELPER PERSONAL FM SYSTEM, Model PFM 300 / PFM 350," which are described as "PERSONAL FM SYSTEMs." FM systems are hardware-based assistive listening devices that typically include a microphone, transmitter, and receiver. The description does not indicate this is a software-only implementation of such a system.
Based on the provided information, 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, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states the device is an "assistive listening device" and a "personal FM system." Its intended use is to "amplify sound for individuals with impaired hearing" and "improve the signal to noise ratio."
- Lack of Biological Sample Testing: There is no mention of the device interacting with or analyzing any biological samples from the human body. Its function is purely related to processing and amplifying sound.
Therefore, this device falls under the category of an assistive hearing device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The indications for use of the assistive listening device in this submission is to amplify sound for individuals with impaired hearing. The device is indicated for individuals with hearing loss in the following category(ies). (Check appropriate space(s)):
Severity:
X 1. Slight
X 2. Mild
X 3. Moderate
Configuration:
X 2. Gradually Sloping
X 4. Flat
Specific Indications (Only if appropriate.):
- FOR IMPROVED SIGNAL TO NOISE RATIO THROUGH PLACEMENT OF A REMOTE MICROPHONE NEAR A DESIRED SOUND SOURCE
- SEVERE TO PROFOUND LOSS - USED IN CONJUNCTION WITH PERSONAL HEARING AID VIA TELECOIL OR DIRECT AUDIO INPUT.
To improve the signal to noise ratio for a listener in a variety of environments where background noise, poor acoustics, and distance from a desired sound source contribute to hearing difficulty.
Any hearing and speech condition that can be improved by maximizing the signal to noise ratio for the listener. This includes: Low gain amplification for Attention Deficit Disorders, Learning Disabilities, Central Auditory Processing Disorders, amplification for mild to moderate conductive and sensorineural hearing loss, and amplification moderate to severe conductive and sensorineural hearing loss when used in conjunction with a personal hearing aid.
Product codes (comma separated list FDA assigned to the subject device)
LZI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (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.
Not Found
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
§ 874.3320 Group hearing aid or group auditory trainer.
(a)
Identification. A group hearing aid or group auditory trainer is a hearing aid that is intended for use in communicating simultaneously with one or more listeners having hearing impairment. The device is used with an associated transmitter microphone. It may be either monaural or binaural, and it provides coupling to the ear through either earphones or earmolds. The generic type of device includes three types of applications: hardwire systems, inductance loop systems, and wireless systems.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
JAN 1 0 2017
Williams Sound Corporation Mr. Paul Ingebrigtsen Vice President, Marketing 10399 West 70th Street Eden Prairie, MN 55344-3459
Re: K970974
Trade/Device Name: Williams Sound, Hearing Personal FM System Model PFM 300/350 Regulation Number: 21 CFR 874.3320 Regulation Name: Group hearing aid or group auditory trainer Regulatory Class: Class II Product Code: LZI Dated: March 11, 1997 Received: March 17, 1997
Dear Mr. Ingebrigtsen:
This letter corrects our substantially equivalent letter of May 2, 1997.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Paul Ingebrigtsen
or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kesia Alexander
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (if known): | 970974 |
|---|---|
| Device Name: | HEARING HELPER ® PERSONAL FM SYSTEM |
| Indications For Use: | Models PFM300 & PFM 358 |
A. General Indications:
The indications for use of the assistive listening device in this submission is to amplify sound for individuals with impaired hearing. The device is indicated for individuals with hearing loss in the following category(ies). (Check appropriate space(s)):
| Severity: | Configuration: | Other |
|---|---|---|
| X 1. Slight | 1. High Frequency - Precipitously Sloping | 1. Low tolerance To Loudness |
| X 2. Mild | X 2. Gradually Sloping | 2. |
| X 3. Moderate | 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.)
- FOR IMPROVED SIGNAL TO NOISE RATIO THROUGH PLACEMENT OF A REMOTE MICROPHONE NEAR A DESIRED SOUND SOURCE
- SEVERE TO PROFOUND LOSS - USED IN CONJUNCTION WITH PERSONAL HEARING AID VIA TELECOIL OR DIRECT AUDIO INPUT.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David C. Seperon
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K970974
Restricted device (per 21 CFR 801.420 & 21 CFR 801.421)
and the commend of the comments of the country
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Williams Sound®
Helping People Hear
Page 1 of .
EXHIBIT 3
INDICATION FOR USE:
510(k) Number (if known):
Device Name: WILLIAMS SOUND, HEARING HELPER PERSONAL FM SYSTEM, Model PFM 300 / PFM 350
Indications for Use:
-1
To improve the signal to noise ratio for a listener in a variety of environments where background noise, poor acoustics, and distance from a desired sound source contribute to hearing difficulty.
Any hearing and speech condition that can be improved by maximizing the signal to noise ratio for the listener. This includes: Low gain amplification for Arention Deficit Disorders, Learning Disabilities, Central Auditory Processing Disorders, amplification for mild to moderate conductive and sensorineural hearing loss, and amplification moderate to severe conductive and sensorineural hearing loss when used in conjunction with a personal hearing aid.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: NA (Per 21CFR 801.109)
10399 West 70th Street
USA
Eden Prairie, MN 55344-3459
OR
Over the Counter: NA
Optional Format 1-2-96
Daniel A. Seaman
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devices 510(k) Number .
510(k) Number K172774
Image /page/3/Picture/16 description: The image shows a logo with the words "Anniversary" in the center. The logo also includes the years "1976" and "1996" on either side of the word "Anniversary". The logo is circular with a jagged edge.
Phone: 800-328-6190 Phone: 612-943-2252 Fax: 612-943-2174
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