audifon Tinnitus-Module

K171243 · Audiofon USA, Inc. · KLW · Oct 19, 2017 · Ear, Nose, Throat

Device Facts

• Record ID: K171243
• Device Name: audifon Tinnitus-Module
• Applicant: Audiofon USA, Inc.
• Product Code: KLW · Ear, Nose, Throat
• Decision Date: Oct 19, 2017
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 874.3400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

audifon Tinnitus-Module is a tool intended to generate sound as part of a Tinnitus Retraining Therapy (TRT) protocol designed to provide temporary relief for people experiencing tinnitus symptoms. The module can be embedded in a hearing aid. audifon Tinnitus-Module is intended for adults over 18 years of age. audifon Tinnitus-Module is targeted for licensed hearing care professionals who are familiar with the evaluation and treatment of tinnitus and hearing losses. The fitting of audifon Tinnitus-Module must be done by a hearing care professional participating in a tinnitus management program.

Device Story

Digital noise generator embedded in hearing aids (ITE, BTE, or RIC housings); generates broadband noise for tinnitus masking/distraction; programmed by hearing care professionals using audifon audifit software and HI-PRO interface; allows adjustment of noise shape (low/high-cut filters) and output levels; provides up to four distinct programs; powered by standard zinc-air hearing aid batteries; output levels monitored via software warnings to prevent exceeding 85 dB A (OSHA guidelines); assists in tinnitus habituation and temporary symptom relief.

Clinical Evidence

Bench testing only. Performance verified per ANSI S3.22-2014 standards. Testing confirmed equivalent acoustic characteristics, frequency range (100-8000 Hz), and effectiveness compared to the predicate device.

Technological Characteristics

Digital noise generator; programmable; 4 programs; low/high-cut filters; output level adjustment; housed in standard ITE, BTE, or RIC hearing aid form factors; powered by 1.4V zinc-air batteries (sizes 10, 312, 13); connectivity via HI-PRO programming box; software-controlled; tested per ANSI S3.22-2014.

Indications for Use

Indicated for adults >18 years experiencing tinnitus symptoms requiring temporary relief via Tinnitus Retraining Therapy (TRT). Targeted for use by licensed hearing care professionals.

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

• audifon vico TRT devices (K130514)

Submission Summary (Full Text)

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October 19, 2017

audiofon USA, Inc. Jane E. Perrone V.P. of U.S. Operations 403 Chairman CT., Suite 1 Debary, FL 32713

Re: K171243

Trade/Device Name: audifon Tinnitus-Module Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus Masker Regulatory Class: Class II Product Code: KLW Dated: September 13, 2017 Received: September 18, 2017

Dear Jane E. Perrone:

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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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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 (DICE) at its toll-free number [phone] or [phone] 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" (21 CFR 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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Srinivas Nandkumar -S

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) K171243

Device Name audifon Tinnitus-Module

Indications for Use (Describe)

audifon Tinnitus-Module is a tool intended to generate sound as part of a Tinnitus Retraining Therapy (TRT) protocol designed to provide temporary relief for people experiencing timitus symptoms. The module in a hearing aid.

audifon Tinnitus-Module is intended for adults over 18 years of age.

audifon Tinnitus-Module is targeted for licensed hearing care professionals who are familiar with the evaluation and treatment of tinnitus and hearing losses. The fitting of audifon Timitus-Module must be done by a hearing care professional participating in a tinnitus management program.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/2 description: The image shows the logo for Audifon hearing systems. The word "audifon" is written in gray letters, except for the "o" which is red. Below the word "audifon" is the phrase "hearing systems" in a smaller, gray font.

#### l. Introduction

| 1. | Applicant's Name and Address: | audifon USA Inc.<br>403 Chairman Ct., Suite 1<br>Debary, Florida 32713<br>PO BOX 531700<br>USA |
|-----|----------------------------------------------|------------------------------------------------------------------------------------------------|
| 2. | Contact Person: | Jane E Perrone<br>Phone: [phone] |
| 3. | Trade or Proprietary Name: | audifon Tinnitus-Module |
| 4. | Device Common Name /<br>Classification Name: | Tinnitus Masker<br>(Regulation Number: 21 CFR 874.3400) |
| 5. | Product Code: | KLW |
| 6. | Classification of Device: | Class II |
| 7. | Type of 510(k) submission | Abbreviated 510(k) |
| 8. | Establishment Registration<br>Number: | 3005384855 |
| 9. | Address of Manufacturing Site: | audifon GmbH& Co. KG<br>Werner-von-Siemens-Str. 2<br>D-99625 Kölleda<br>Germany |
| 10. | Predicate Device Identification: | K130514<br>audifon vico TRT devices |
| 11. | Date of Preparation | April 02, 2017 |

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Image /page/4/Picture/2 description: The image shows the logo for Audifon hearing systems. The word "audifon" is written in gray letters, with the "o" in "audifon" being red. Below the word "audifon" is the phrase "hearing systems" in a smaller, gray font.

#### Indications for Use .

audifon Tinnitus-Module is a tool intended to generate sound as part of a Tinnitus Retraining Therapy (TRT) protocol designed to provide temporary relief for people experiencing tinnitus symptoms. The module can be embedded in a hearing aid.

audifon Tinnitus-Module is intended for adults over 18 years of age.

audifon Tinnitus-Module is targeted for licensed hearing care professionals who are familiar with the evaluation and treatment of tinnitus and hearing losses. The fitting of audifon Tinnitus-Module must be done by a hearing care professional participating in a tinnitus management program.

#### . Description of Device

The above mentioned audifon Tinnitus module is a digital noise generator which was developed to be used in a tinnitus retraining therapy. This product has up to four different programs, which can be programmed in shape and level to fit the individual user's needs. The programming can be done with a standard HI-PRO and the audifon audifit software. Within the software the amplification of the device can be fitted to the individual needs. The noise can be adjusted in shape with low- and high-cut filters and in the output level. It can be housed in a standard In-the-ear instrument housing, in a standard behind-the-ear instrument housing as well as in standard receiver-in-the ear housing.

#### IV. Comparison Information to Predicate Device

The mentioned devices are substantially equivalent to the audifon vico TRT devices (K130514). The mentioned devices and the audifon vico TRT devices are fully digital masker, with programmable noises. Within the program the level and the shape of the noise can be adjusted. Also the mentioned devices and the audifon vico TRT devices provide an additional amplification and can be programmed with the fitting software and a standard HI-PRO programming box.

The non-clinical performance data which were measured according to official standards (ANSI S3.22-2014) verify that the devices have a similar effectiveness as the predicate device. For TRT therapy sound level below 80 dB SPL are needed. Level above 80 dB SPL usually not used. Furthermore. as described within the OSHA (29CFR 1910.95) the output level should not exceed 85 dB A. Therefore a warning in the software will occur that higher level should not be used or only in case of a hearing loss. So the lower maximum output has no influence on the effectiveness of the devices.

The frequency range provides an equivalent white noise with the same sound quality.

In conclusion, the non-clinical tests demonstrate that the submitted devices are as safe as effective the predicate device and the performance are as well as the predicate device.

The submission for tinnitus masker relies on a special control that is defined in section 874.3400. The special controls are identical applied as with the predicate device and supports the substantial equivalence.

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The following tables compare the submitted devices and the audifon vico TRT devices.

| | audifon device with active audifon<br>Tinnitus-Module | audifon vicoTRT family |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For<br>Use | audifon Tinnitus- Module is a tool<br>intended to generate sound as part of<br>a Tinnitus Retraining Therapy (TRT)<br>protocol designed to provide<br>temporary relief for people<br>experiencing tinnitus symptoms. The<br>module can be embedded in a hearing<br>aid.<br>audifon Tinnitus- Module is intended<br>for adults over 18 years of age.<br>audifon Tinnitus- Module is targeted<br>for licensed hearing care professionals<br>who are familiar with the evaluation<br>and treatment of tinnitus and hearing<br>losses. The fitting of audifon Tinnitus-<br>Module must be done by a hearing<br>care professional participating in a<br>tinnitus management program. | The combined devices are intended<br>for persons suffering from a chronic<br>persistent ringing in the ears (Tinnitus)<br>in combination with a mild to moderate<br>hearing loss that is indicated for a<br>hearing aid fitting. The products may<br>be used for masking Tinnitus as part<br>of a Tinnitus Retraining Therapy (TRT)<br>protocol and should be utilized only in<br>consultation with a qualified hearing<br>healthcare professional. The devices<br>provide hearing aid amplification to<br>compensate for the hearing loss as<br>well as broadband noise for immediate<br>distraction or masking of Tinnitus or<br>long term habituation of Tinnitus. |
| Operation /<br>Mechanism | Uses broadband noise; Manages<br>tinnitus through masking and<br>distraction<br>Digital<br>Circuit type:<br>Programmable:<br>Yes<br>Available noises:<br>Four<br>Volume control:<br>Yes<br>white-noise is adjustable<br>noise level is programmable<br>adjustable Low Battery Indicator<br>programmable Program Switch Tones | Uses broadband noise; Manages<br>tinnitus through masking and<br>distraction<br>Digital<br>Circuit type:<br>Programmable:<br>Yes<br>Available noises:<br>Four<br>Volume control:<br>Yes<br>white-noise is adjustable<br>noise level is programmable<br>adjustable Low Battery Indicator<br>programmable Program Switch Tones |
| Where Used | May be used anywhere | May be used anywhere |
| Physical<br>Description | Standard In-the-ear instrument<br>housing<br>Standard behind-the-ear instrument<br>housing<br>Standard receiver-in-the-ear<br>instrument housing | Standard In-the-ear instrument<br>housing<br>Standard behind-the-ear instrument<br>housing |
| | audifon device with active audifon<br>Tinnitus-Module | audifon vicoTRT family |
| Maximum<br>Output<br>Characteristics | White noise: 100 - 112 dB SPL<br>frequency range:100 - 8000 Hz | White noise: 107 - 116 dB SPL<br>frequency range: 100 - 8000 Hz |
| Power Source | standard 10 zinc air 1,4V hearing aid<br>battery<br>standard 312 zinc air 1,4V hearing aid<br>battery<br>standard 13 zinc air 1,4V hearing aid<br>battery | standard 10 zinc air 1,4V hearing aid<br>battery<br>standard 312 zinc air 1,4V hearing aid<br>battery<br>standard 13 zinc air 1,4V hearing aid<br>battery |
| Quality<br>Assurance<br>Standard | ANSIS3.22-2014 to ensure proper<br>functioning of HA | ANSIS3.22-2014 to ensure proper<br>functioning of HA |

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Image /page/6/Picture/2 description: The image shows the Audifon hearing systems logo. The word "audifon" is written in gray letters, except for the "o" which is red. Below the word "audifon" is the phrase "hearing systems" in smaller gray letters.

#### Conclusion V.

- The devices have similar operating mechanisms as the predicate device. ●
- . The devices have similar acoustic characteristics as the predicate device.
- The devices are similar in style as the predicate device. .
- The devices are similar in intended use as the predicate device .
- The devices have the same targeted population as the predicate device