WILLIAMS SOUND, PERSONAL FM SYSTEM, HEARING HELPER by WILLIAMS SOUND, LLC

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: Slight, Mild, Moderate. Configuration: Gradually Sloping, Flat.
Specific Indications: 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.

Device Description

HEARING HELPER PERSONAL FM SYSTEM Models PFM300 & PFM 358. WILLIAMS SOUND, HEARING HELPER PERSONAL FM SYSTEM, Model PFM 300 / PFM 350.

AI/ML Overview

The provided text is a 510(k) premarket notification for a hearing assistance device, the Williams Sound, Hearing Personal FM System Model PFM 300/350. This type of regulatory submission historically focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance studies with acceptance criteria as one might find for a novel or high-risk device.

Based on the information provided, it is not possible to describe specific acceptance criteria and a study proving the device meets them in the way modern device submissions or clinical trials would. Here's why and what can be extracted:

Type of Device and Submission: This is a Class II group hearing aid or group auditory trainer. The document is a 510(k) premarket notification, which primarily establishes "substantial equivalence" to a legally marketed predicate device. This process typically involves comparing technical characteristics and indications for use, rather than extensive clinical efficacy studies with predefined acceptance criteria and statistical power calculations.
Date: The letter is dated January 10, 2017, but refers to the original 510(k) submission from 1997 (K970974) and a correction letter from 1997. Regulatory requirements and expectations for performance studies have evolved significantly since 1997.

Therefore, the following points address what can be inferred or what is not present in the provided text regarding acceptance criteria and a detailed study:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Inferred/Typical for 510(k))	Reported Device Performance (From Document)
Substantial Equivalence:	The FDA has "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..." (Page 0). This is the primary "performance metric" for a 510(k) in the absence of specific clinical efficacy claims requiring trials.
Indications for Use:	General Indications (Page 2): "amplify sound for individuals with impaired hearing." Indicated for hearing loss severity: Slight, Mild, Moderate. Indicated for hearing loss configuration: Gradually Sloping, Flat. Specific Indications (Page 2): "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." Further Indications (Page 3): "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."
Safety and Effectiveness:	The FDA states, "You may, therefore, market the device, subject to the general controls provisions of the Act." This implies the device is deemed safe and effective for its intended use based on the substantial equivalence review, but no specific outcome measures or performance thresholds are explicitly stated in this document.

Here are the answers to the specific questions, based on the provided document:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not mentioned. The document describes a 510(k) premarket notification for substantial equivalence, which typically relies on comparisons of technical characteristics and indications of use to a predicate device, rather than a clinical "test set" with human subjects. If any testing was done, it would likely be engineering bench testing for acoustic performance rather than human performance testing that would require a "test set" in the clinical sense.
Data Provenance: Not mentioned. It's highly unlikely that clinical data from a human test set was a primary component of this 1997 510(k) submission for this type of device, given the regulatory landscape at the time and the nature of substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not mentioned. As there is no clinical "test set" described, there would be no ground truth established by experts in this context. The "ground truth" for a 510(k) is the predicate device's established safety and effectiveness.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not mentioned. No clinical test set or adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is a hearing assistance device, not an AI-powered diagnostic tool, and the concept of "human readers" or "AI assistance" is not applicable here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a hardware hearing system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For a 510(k), the "ground truth" for the submission is the established safety and effectiveness profile of the predicate device. The applicant demonstrates that their new device is "substantially equivalent" to this predicate, meaning it performs similarly and raises no new questions of safety or effectiveness. No specific clinical ground truth (like pathology or outcomes data) is typically required for this type of device and submission.

8. The sample size for the training set

Not applicable/Not mentioned. This is a hardware device; there is no "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set."

Summary

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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:

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:

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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

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

Regulation Number and Section

§ 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.