PHONAK TINNITUS BALANCE

K123450 · Phonak, LLC · KLW · Feb 11, 2013 · Ear, Nose, Throat

Device Facts

• Record ID: K123450
• Device Name: PHONAK TINNITUS BALANCE
• Applicant: Phonak, LLC
• Product Code: KLW · Ear, Nose, Throat
• Decision Date: Feb 11, 2013
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 874.3400
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Broadband noise generator embedded in firmware of Phonak hearing aids; provides sound enrichment for tinnitus management. Operated by licensed hearing healthcare professional (audiologist, hearing aid specialist, otolaryngologist) during fitting; patient uses device daily for combined tinnitus relief and amplification. HCP adjusts spectral characteristics based on patient audiogram or white noise settings. Output is constant-level broadband noise (max 85 dB(A) SPL). Device helps defocus user attention from tinnitus; enables single-device solution for hearing loss and tinnitus.

Clinical Evidence

No clinical data. Safety and effectiveness supported by risk analysis, design verification/validation, and review of published scientific literature.

Technological Characteristics

Broadband noise generator software embedded in digital hearing aid firmware. Maximum noise output limited to 85 dB(A) SPL. Features adjustable spectral characteristics. Connectivity varies by hearing aid model (wireless/non-wireless).

Indications for Use

Indicated for adults 18+ with tinnitus desiring amplification. Requires assessment by a licensed ear physician to rule out contraindications: visible ear deformity, active drainage (past 90 days), sudden hearing loss (past 90 days), acute/chronic dizziness, unilateral sudden hearing loss (past 90 days), or ear pain/discomfort.

Regulatory Classification

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.

Special Controls

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.

Predicate Devices

• Tinnitus Sound Generator Module, GN ReSound A/S (K110932)
• IE-Zen (in CLEAR series hearing aid), Widex USA (K110973)
• TCI-Combi, Siemens Hearing Instruments (K003558)

Submission Summary (Full Text)

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K123450

## 5. 510(k) Summary

# FEB 1 1 2013

| Submitter: | Phonak, LLC | |
|----------------------|----------------------------------------------|-------------------------------------------------|
| | 4520 Weaver Parkway | |
| | Warrenville, IL 60555 | |
| Contact Person: | Laura Ellman | |
| | [phone] | |
| 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

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. ﭘﮩﺎﻧ

#### 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.

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## 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.

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### 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.

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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

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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 [phone] or [phone] 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

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# 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.

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

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
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