Sound Field wireless amplification systems are intended for use as group auditory trainers used to communicate simultaneously with one or more listeners with normal hearing or hearing impairments. The device is used with an associated transmitter microphone and speaker systems and does not provide coupling to the ear through either earphones or earmolds.

These systems use FM and/or infrared wireless technology which include receivers, transmitters, and strategic placement of high quality speaker systems and can be used with or without BTF hearing aids and/or personal FM devices. The talker's voice with or which bI E throughout the room to assist listeners, regardless of seating location, to consistently hear what the talker is saying.

Device Description

Sound Field group amplification systems consist of FM or IR transmitters and microphone used by a speaker/instructor to send auditory signals to FM or IR receiver/amplifier which noreesses the voice signals and broadcast the signals through one or more loudspeakers. These systems are generally installed under the guidance of an audiologist or a sound contractor. Sound Field systems consist of an on/off switch and volume controls. Specifications and user guider in cre provided for Sound Field installation and use.

Sound Field systems are assembled from standard electronic components widely used by Group Hearing Aid and Group Auditory Trainer manufacturers. Sound Field wireless ampification systems amplify and broadcast the speaker/instructor's voice through strategically-mnounted.will and/or ceiling loud speakers placed throughout the listening area to distribute the final moder want signal (sound) of the speaker/instructor and are not directly connected or coupled to the piroener.

Sound Field wireless amplification systems are intended for use as group auditory trainers used to communicate simultaneously with one or more listeners with normal hearing on he aring impairments. The device is used with an associated transmitter microphone and speakers systems and does not provide coupling to the ear through either earphones or earmolds.

These systems use FM and/or infrared wireless technology which include receivers, transmitters, and strategic placement of high quality speaker systems and can be used with or without BTE hearing aids and/or personal FM devices. The talker's voice is mildly amplified and dispersed throughout the room to assist listeners, regardless of seating location, to consistently bear what the talker is saying.

AI/ML Overview

The provided text K043090 includes a 510(k) summary for Phonic Ear Sound Field Group Amplification Systems. However, it does not contain a study that proves the device meets specific acceptance criteria through performance metrics or statistical analysis.

Instead, the document states:

"Many case studies, experiments, and trials exist that document the benefits and effectiveness of speech perception from Sound Field amplification." Crucially, it does not provide details of these specific studies that were conducted for this device to establish acceptance criteria and performance against them.
"Field studies were conducted in accordance with ANSI S12.60 Acoustical Performance Criteria, Design Requirements, and Guidelines for Schools." Again, specific results, acceptance criteria, or performance data from these particular field studies are not included.
"Test procedures to obtain FCC (Federal Communications Commission) approval are in accordance with good engineering practices and in accordance with FCC Rules, Part 15, Subpart A, 15, 19 (a) (3) and (C) Code of Federal Regulations (CFR 47)." This refers to regulatory compliance for radio frequency emissions, not clinical performance or efficacy.

Therefore, based solely on the provided text, it is not possible to complete most of the requested sections as the necessary information (specific acceptance criteria, detailed study results, sample sizes for test/training, ground truth establishment, expert qualifications, etc.) is absent. The submission relies on establishing substantial equivalence to predicate devices (K974287) and generally referencing existing literature and compliance with technical standards (ANSI, FCC) rather than presenting a novel performance study with defined acceptance criteria for the current device.

Here's a breakdown of what can and cannot be answered from the provided text:

Description of Acceptance Criteria and Device Performance Study (Based on Provided Text)

Unfortunately, the provided 510(k) summary for the Phonic Ear Sound Field Group Amplification Systems does not include specific acceptance criteria or a detailed study that measures the device's performance against such criteria. The submission focuses on establishing substantial equivalence to predicate devices and adherence to existing standards (ANSI S12.60 for acoustics and FCC for radio frequency emissions).

The document mentions that "Many case studies, experiments, and trials exist that document the benefits and effectiveness of speech perception from Sound Field amplification," and "Field studies were conducted in accordance with ANSI S12.60." However, it does not present the results of these or any new studies conducted specifically for this device against defined performance acceptance criteria.

Therefore, a table of acceptance criteria and reported device performance cannot be created from this document. The following sections are addressed where information is available, and marked as "Not provided in the text" otherwise.

A table of acceptance criteria and the reported device performance

Acceptance Criteria Reported Device Performance
Not provided in the text Not provided in the text
- The document implies adherence to "ANSI S12.60 Acoustical Performance Criteria, Design Requirements, and Guidelines for Schools" and FCC regulations, but it does not specify quantitative acceptance criteria derived from these standards for the device, nor does it provide performance data to demonstrate compliance.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not provided in the text.
- Data Provenance: Not provided in the text. The document refers generally to "Field studies were conducted" but gives no details about the participants, methodology, or geographical origin.
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 provided in the text. The type of study described (adherence to acoustical standards, and general benefit of sound field amplification) does not typically involve expert "ground truth establishment" in the same way an AI diagnostic device would.
Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable/Not provided in the text. No details of a test set and associated adjudication method are present.
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
- Not applicable. This device is a sound amplification system, not an AI diagnostic tool designed to assist human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device's function and was not performed.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an auditory trainer and amplifier, not a standalone algorithm. Its performance is inherently tied to its physical components and how it processes and broadcasts sound for human listeners.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not provided in the text. For a sound amplification system, "ground truth" would likely relate to objective acoustical measurements (e.g., sound pressure levels, speech intelligibility index, signal-to-noise ratio) and subjective listener perception. However, no specific ground truth methodology or data is detailed in the submission for this device's performance.
The sample size for the training set
- Not applicable. This device is a hardware-based amplification system, not a machine learning algorithm requiring a "training set."
How the ground truth for the training set was established
- Not applicable. As above, this device does not use a training set for machine learning.

Acceptance Criteria	Reported Device Performance
Not provided in the text	Not provided in the text

Summary

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K043090

DFC 2 3 2004

Phonic Ear, Inc. Office of Regulatory Affairs & QMS Sound Field Group Amplification Systems - 510(k) Section C

510(k) Summary

Phonic Ear, Inc. 3880 Cypress Drive Petaluma, California 94954-7600

Establishment Registration No. 2918633

Mr. Michael Gibbs Telephone Number: (707)769-1110 Ext. 247 Fax Number: (707) 769-9624

Device Trade or Proprietary Names:	EasyListener 2 FM Sound Field SystemRadium FM Sound Field SystemVocalight Infrared Sound Field System
Device Common Name:	Sound Field Amplification Systems
Classification Name:	Group Hearing Aid or Group Auditory Trainer
Device Classification:	Class II
Regulation Number:	874.3320
Product Code:	EPF

Intended Use of the Device:

Sound Field wireless amplification systems are intended for use as group auditory trainers used to communicate simultaneously with one or more listeners with normal hearing on he aring impairments. The device is used with an associated transmitter microphone and speaker systems and does not provide coupling to the ear through either earphones or earmolds.

These systems use FM and/or infrared wireless technology which include receivers, transmitters, and strategic placement of high quality speaker systems and can be used with or without BTE hearing aids and/or personal FM devices. The talker's voice is mildly amplified and dispersed throughout the room to assist listeners, regardless of seating location, to consistently beap what the talker is saying.

Identification of predicate devices :

Sound Field systems are substantially equivalent to various types of approved Group Hearing-Aids or Group Auditory Trainers that are directly connected or coupled to the listener as described above with similar results:

K974287 – FM Receiver Group Auditory Trainer-Solaris Binaural Hearing System

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Phonic Ear, Inc. Office of Regulatory Affairs & OMS Sound Field Group Amplification Systems - 510(k) Section C

Description of the candidate devices :

These systems use FM and/or infrared wireless technology which include receivers, transmitters, and strategic placement of high quality speaker systems and can be used with or without BTE hearing aids and/or personal FM devices. The talker's voice is mildly amplified and dispersed throughout the room to assist listeners, regardless of seating location, to consistently bear what the talker is saying.

There are no known contraindications associated with the use of Sound Field group amplification systems. Many case studies, experiments, and trials exist that document the benefite and effectiveness of speech perception from Sound Field amplification.

Field studies were conducted in accordance with ANSI S12.60 Acoustical Performance Criteria, Design Requirements, and Guidelines for Schools. Prior to the issuance of ANSI S12.60 in 2002 there were no known performance standards or special controls for Sound Field ampification systems.

Test procedures to obtain FCC (Federal Communications Commission) approval are in accordance with good engineering practices and in accordance with FCC Rules, Part 15, Subpart A, 15, 19 (a) (3) and (C) Code of Federal Regulations (CFR 47).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 3 2004

Phonic Ear, Inc. c/o Mr. Michael L. Gibbs Regulatory Affairs & QMS Manager Corporate Headquarters 3880 Cypress Drive Petaluma, CA 94928

Re: K043090

Trade/Device Name: Phonic Ear Sound Field Group Amplification Systems Regulation Number: 21 CFR 874.3320 Regulation Name: Group Hearing Aid, Group Auditory Trainer Regulatory Class: Class II Product Code: LZI Dated: November 30, 2004 Received: December 2, 2004

Dear Mr. Gibbs:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act 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 807); labeling (21 CFR Part 801); 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A halpi korenthal

A. Ralph Rosenthal, 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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Phonic Ear, Inc. Office of Regulatory Affairs & OMS Sound Field Group Amplification Systems - 510(k) Section D

Indications for Use

510(k) Number (if known): K043090

Device Name: Phonic Ear Sound Field Group Amplification Systems

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use X (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Over-the-Counter Use

sion of Ophthalr se and Throat De

510(k) Number K043090

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.