The Tinnitus Balance software feature and accompanying hearing aid amplification is fit by a licensed hearing healthcare professional (audiologist, hearing aid specialist, notolaryngologist) familiar with the diagnosis and management of tinnitus. Phonak hearing aids provide amplification to address sensorineural, conductive, or mixed hearing losses. Depending on the specific model, Phonak hearing aids cover fitting ranges from mild to profound hearing losses.

Before being fit with Tinnitus Balance, individuals presenting with tinnitus should be assessed by a licensed ear physician to confirm the source of their tinnitus is not due to any of the following medical conditions:

• Visible congenital or traumatic deformity of the ear

· Any active drainage from the ear within the previous 90 days

· Sudden hearing loss within the previous 90 days

· Acute or chronic dizziness

• Unilateral hearing loss of sudden or recent onset within the previous 90 days

• Pain or discomfort in the ear

Device Description

The Tinnitus Balance software feature is a broadband noise generator embedded in the firmware of selected Phonak hearing aids. It provides a means of sound enrichment that can be used as part of a tinnitus management program to provide relief from tinnitus. By combining a broadband noise generator and hearing aid, the patient is able to wear a single device throughout the day for both tinnitus relief and amplification. The Tinnitus Balance software is enabled and fit by a licensed hearing healthcare professional together with the hearing aid's amplification to meet the individual needs of the patient.

AI/ML Overview

The provided 510(k) summary for the Phonak Tinnitus Balance software feature lacks detailed performance study information, acceptance criteria, and specific data regarding ground truth establishment as typically found in comprehensive regulatory submissions. This device was cleared in 2013, and regulatory requirements and documentation standards have evolved significantly since then.

Based on the available document, here's what can be inferred:

Acceptance Criteria and Device Performance

The document does not explicitly state quantitative acceptance criteria or report specific device performance metrics in a readily quantifiable format. Instead, it relies on a comparison to predicate devices and a general statement of safety and effectiveness.

Acceptance Criteria Category	Specific Criteria (Inferred/Missing)	Reported Device Performance (Inferred/Missing)
Safety	No new safety concerns introduced.	"Performance testing of the Tinnitus Balance software feature indicates it is safe..."
Effectiveness	Performs as well as predicate devices for tinnitus management.	"...effective and performs as well as the predicate devices."
Intended Use Fulfillment	Provides supplementary noise for tinnitus relief and amplification for those desiring it.	Device description and intended use section confirms these functionalities.
Technical Specifications	Not explicitly stated but implied through comparison with predicates: - Broadband noise generation. - Embeddable in digital hearing aid platforms. - Max output of generated noise limited to 85 dB(A) SPL. - Volume adjustment capability. - Spectral characteristics adjustable by HCP.	The document extensively compares its technical features to three predicate devices, highlighting commonalities and differences.

Study Details

The document mentions "Performance Testing" and a "review of published scientific literature" but does not describe a specific clinical trial or study with detailed methodology as per modern standards.

Sample size used for the test set and the data provenance: Not specified. The document states "Performance Testing" was conducted and a "review of published scientific literature" was performed. This implies reliance on existing knowledge rather than a new clinical study with a defined test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. Given the nature of a tinnitus masker, ground truth would typically relate to user perception of tinnitus relief, sound characteristics, and safety. There is no mention of experts establishing a ground truth for a test set.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable based on the provided information, as no formal test set with ground truth adjudication is described.
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 tinnitus masker, not an AI-assisted diagnostic tool that would involve "human readers" or image interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a standalone algorithm (software feature) embedded in a hearing aid, providing noise generation without requiring continuous human interaction during its operation for tinnitus relief. However, "standalone performance" in the context of typical AI medical device studies often refers to the algorithm's diagnostic accuracy without human input. For this device, the "standalone performance" would relate to its ability to generate the specified noise and integrate with the hearing aid's amplification, which is covered by general performance testing and comparison to predicates.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly stated. For a tinnitus masker, "ground truth" would likely be based on objective sound output measurements, subjective patient feedback regarding tinnitus perception and comfort, and the ability of the device to deliver the intended sound therapy within safe limits. The document only mentions "review of published scientific literature to confirm the safety and effectiveness."
The sample size for the training set: Not applicable. This device is a software feature implementing a broadband noise generator; it is not an AI/ML algorithm that requires a "training set" in the conventional sense. Its design is based on established principles of sound therapy for tinnitus.
How the ground truth for the training set was established: Not applicable, as there is no "training set."

In summary:

The 510(k) for the Phonak Tinnitus Balance software feature relies heavily on predicate device comparison and a general statement of safety and effectiveness based on risk analysis, verification/validation, and scientific literature review. It does not present a detailed prospective clinical study with specific acceptance criteria, test sets, ground truth establishment, or human reader performance metrics characteristic of advanced AI/ML device clearances. This is consistent with regulatory submissions for certain types of Class II medical devices, especially those cleared around 2013, which leverage substantial equivalence to existing technologies.

Summary

{0}------------------------------------------------

K123450

5. 510(k) Summary

FEB 1 1 2013

Submitter:	Phonak, LLC
	4520 Weaver Parkway
	Warrenville, IL 60555
Contact Person:	Laura Ellman
	(630) 821-5000
Date Prepared:	October 1st 2012, revised January 21st, 2013
Device Name:	Phonak Tinnitus Balance software feature
Classification Name:	Tinnitus Masker
Product Code:	KLW
Predicate Devices:	K110932	Tinnitus Sound Generator Module, GN ReSound A/S
	K110973	IE-Zen (in CLEAR series hearing aid), Widex USA
	K003558	TCI-Combi, Siemens Hearing Instruments

Description of Device

Intended Use

The Phonak Tinnitus Balance software feature is intended for use by people with tinnitus who also desire amplification. It provides supplementary noise stimulation which can help defocus the user's attention from their tinnitus. The initial spectral characteristics of Tinnitus Balance can either be determined by the patient's audiogram as measured by the hearing healthcare professional, or broadband white noise. The spectral characteristics can be adjusted by the HCP to fit the needs of the patient as part of their customized tinnitus management program.

{1}------------------------------------------------

Technological comparison to predicate devices

The Tinnitus Balance software feature shares the same basic technology used by the three predicate devices. It shares the following technological principles with the GN ReSound Tinnitus Sound Generator Module predicate device (K110932):

Embeds a broadband noise generator software feature in a digital hearing aid platform
Feature can be made available in multiple hearing programs during fitting and uses a similar . approach for volume adjustment by the patient

Principles that differ from Tinnitus Sound Generator Module are:

. Maintains the noise at a constant output level for the patient as specified during fitting and does not vary the amplitude or frequency
. Limits the maximum output of the generated noise to 85 dB(A) SPL independent of maximum hearing aid output

The Tinnitus Balance software feature shares the following technological principles with the IE-Zen (in CLEAR series hearing aid) predicate device (K110973):

. Embeds a noise generator software feature in a digital hearing aid platform comprising wireless hearing aid models
. Feature can be made available in multiple hearing programs during fitting and uses a similar approach for volume adjustment by the patient

Principles that differ from IE-Zen are:

. Provides only a broadband noise generator and no musical tones
. Limits the maximum output of the generated noise to 85 dB(A) SPL independent of maximum hearing aid output

The Tinnitus Balance software feature shares the following technological principles with the TCI-Combi predicate device (K003558):

♥ Embeds a broadband noise generator software feature in a digital hearing aid platform comprising non-wireless hearing aid models
. Feature can be made available in multiple hearing programs during fitting and uses a similar approach for volume adjustment by the patient

Principles that differ from TCI-Combi are:

. Limits the maximum output of the generated noise to 85 dB(A) SPL independent of maximum hearing aid output
The Tinnitus Balance software feature does not introduce any new types of generated noise or levels that may introduce safety or effectiveness concerns.

{2}------------------------------------------------

Performance Testing

Phonak has conducted a risk analysis and performed the necessary verification and validation activities to demonstrate the design outputs meet the design inputs of the Tinnitus Balance software feature.

Phonak has conducted a review of published scientific literature to confirm the safety and effectiveness of the Tinnitus Balance software feature in line with the stated intended use.

Conclusion

Performance testing of the Tinnitus Balance software feature indicates it is safe, effective and performs as well as the predicate devices.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

February 11, 2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Phonak, LLC % Ms. Laura Ellman Quality Manager 4520 Weaver Parkway Warrenville, IL 60555

Re: K123450

Trade/Device Name: Phonak Tinnitus Balance software feature Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus Masker Regulatory Class: Class II Product Code: KLW Dated: October 30, 2012 Received: November 13, 2012

Dear Ms. Ellman:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your beceion of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use suited in the encreations of the enactment date of the Medical Device Amendments, or to conninered pror to 112) 2011-07-11 in accordance with the provisions of the Federal Food, Drug, de rices that have been 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 The general controls proving practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability addition. Thease note: "SDAT as , 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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r load be act not a letermination that your device complies with other requirements of the Act that I DX has made a detern regulations administered by other Federal agencies. You must or any I coural statutes and seguirements, including, but not limited to: registration and listing (21

{4}------------------------------------------------

Page 2 - Ms. Laura Ellman

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set de rece related darers or one of the end to (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 11 you desire specific aboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for go to mep. 7. www.radi.org.cal Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note the regulations 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 Small Manufacturers, International and Consumer Assistance 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,

Eric A. Mann 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

{5}------------------------------------------------

Indications for Use

510(k) Number (if known): K123450

Phonak Tinnitus Balance software feature Device Name:

Indications For Use:

The target group for the Phonak Tinnitus Balance software feature are adults 18 years of age or older with tinnitus who also desire amplification.

• Visible congenital or traumatic deformity of the ear

· Any active drainage from the ear within the previous 90 days

· Sudden hearing loss within the previous 90 days

· Acute or chronic dizziness

• Unilateral hearing loss of sudden or recent onset within the previous 90 days

• Pain or discomfort in the ear

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

Over-The-Counter Use : (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

A. George
Division Sign-Off

and Throat Devices 510(k) Number

Page 1 of

Regulation Number and Section

§ 874.3400 Tinnitus masker.

(a)
Identification. A tinnitus masker is an electronic device intended to generate noise of sufficient intensity and bandwidth to mask ringing in the ears or internal head noises. Because the device is able to mask internal noises, it is also used as an aid in hearing external noises and speech.(b)
Classification. Class II. The special control for this device is patient labeling regarding:(1) Hearing health care professional diagnosis, fitting of the device, and followup care,
(2) Risks,
(3) Benefits,
(4) Warnings for safe use, and
(5) Specifications.