Serenity

K150014 · Sanuthera, Inc. · KLW · Jul 27, 2015 · Ear, Nose, Throat

Device Facts

• Record ID: K150014
• Device Name: Serenity
• Applicant: Sanuthera, Inc.
• Product Code: KLW · Ear, Nose, Throat
• Decision Date: Jul 27, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sanuthera's Serenity device is indicated to provide a mean of sound enrichment therapy that is programmed by a hearing health care professional familiar with diagnosis and management of tinnitus as part of a personalized tinnitus management program to provide temporary relief from the tinnitus symptoms.

Device Story

Serenity is a plug-in sound therapy device for the Unitron uDirect2 bridge; it works with Unitron Moxi Kiss BTE hearing aids. The device generates sounds to obscure tinnitus or facilitate habituation. A hearing healthcare professional customizes the device using software to set filter and volume parameters based on the patient's tinnitus profile. The device uses an onboard processing unit and digital band-pass filter to manipulate sound frequency and volume. The system includes a battery charger for the Serenity and uDirect2. The output is wirelessly transmitted to ear-level hearing aids. The device helps patients defocus from tinnitus, providing temporary symptom relief. Usage is limited by the hearing aid's Maximum Power Output (MPO) to prevent hearing damage.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Plug-in module for uDirect2 bridge; utilizes onboard processing unit and digital band-pass filter. Frequency response up to 10,000 Hz. Maximum output limited by hearing aid MPO (max 85 dBA SPL for 8-hour daily use). Connectivity: wireless transmission to BTE hearing aids. Software-based customization of sound/noise filtering and volume.

Indications for Use

Indicated for adult population over 18 years of age for temporary relief of tinnitus symptoms via sound enrichment therapy.

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

• Unitron Tinnitus Masker Feature (K130494)

Submission Summary (Full Text)

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 27, 2015

Sanuthera, Inc. Mr. Jeffery DiGiovanni President 340 West State Street, Unit 45 Athens, Ohio 45701

Re: K150014 Trade/Device Name: Serenity Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus Masker Regulatory Class: Class II Product Code: KLW Dated: June 22, 2015 Received: June 25, 2015

Dear Mr. DiGiovanni:

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.

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.

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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 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 [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 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 -S

for Malvina B. Eydelman, M.D. Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Section 4: Indication for Use Summary

| 510(k) Number (if known): | K150014 |
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| Device Name: | Serenity |

### Indications For Use:

The Sanuthera's Serenity device is indicated to provide a mean of sound enrichment therapy that is programmed by a hearing health care professional familiar with diagnosis and management of tinnitus as part of a personalized tinnitus management program to provide temporary relief from the tinnitus symptoms.

The target population is primarily the adult population over 18 years of age.

Prescription Use _ X (Per 21 CFR 801.109)

OR

Over-The-Counter-Use _

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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# Section 5: 510k) Summary

The Summary of Safety and Effectiveness information on the Sanuthers, Inc. Serenity is being submitted in accordance of 21 C.F.R. §807.92 and reflects data available and represented at the time the submission was prepared, but caution should be execised in interpreting the data. The results of future studies and or tests may require alterations of the conclusions or forth.

#### SUBMITTER I.

| Applicant: | Sanuthera, Inc.<br>340 West State Street<br>Unit 45<br>Athens, Ohio 45701 |
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| Telephone: | 740-591-1410 |
| Facsimile: | 928-396-9094 |
| Contact: | Jeffery DiGiovanni |
| Date Prepared: | December 29, 2014 |

#### II. DEVICE

| Name: | Serenity |
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| Common Name: | Tinnitus Masking Device |
| Classification Name: | Tinnitus Masker, 21 CFR §874.3400 |
| Regulatory Class: | Class II |
| Product Code: | KLW |

# III. PREDICATE DEVICE

| Predicate: | Unitron Tinnitus Masker Feature, K130494, with market clearance date of<br>May 7, 2013 |
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### IV. DEVICE DESCRIPTION

| Description: | Sanuthera's Serenity is a device utilizing sound therapy as a means to mitigate the symptoms associated with tinnitus. The Serenity device works as a plug-in device to the uDirect2 bridge device, manufactured by a hearing- aid company Unitron and can be customized to a patient's tinnitus profile and then adjusted to his/her preference to play a number of sounds aimed at obscuring the ringing in the patient's ear and/or re-train patients to avoid focusing on the ringing, essentially “habituating” them away from the disease. |
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| | The process of providing tinnitus therapy occur a number of ways although the most popular are Tinnitus Retraining Therapy (TRT) and Tinnitus Masking (TM). In either case, the patient is provided with the Serenity device which is custom programmed. The patient is then taken through a process of multiple protocols to set filter and volume parameters via an onboard processing unit and an onboard digital band pass filter to slowly assist in the habituation to the tinnitus. |

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### IV. DEVICE DESCRIPTION, continue

| Associated Accessories: | The following are part of the Serenity system: |
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| | • The Software that is utilized by an audiologist to customize, per<br>patient's preference during the device fitting process, the sounds<br>aimed at obscuring the ringing in the patient's ear and/or re-train |
| | patients to avoid focusing on the ringing. |
| | The Unitron's commercially available neck-worn uDirect2 bridge<br>●<br>device with Unitron's Moxi Kiss Behind-the-Ear family hearing aids<br>(K130494). |
| | • The battery charger to simultaneously charge in parallel the batteries<br>of the Serenity and the uDirect2 bridge device. |

#### v. INDICATION FOR USE

| Indication For Use: | The Sanuthera's Serenity device is indicated to provide a mean of sound<br>enrichment therapy that is programmed by a hearing health care professional<br>familiar with diagnosis and management of tinnitus as part of a personalized<br>tinnitus management program to provide temporary relief from the tinnitus<br>symptoms.<br><br>The target population is primarily the adult population over 18 years of age. |
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### VI. COMPARISION OF TECHNOLOGICAL CHARACTERISTIC WITH PREDICATE DEVICE

| Substantial Equivalency<br>Information: | The underlying principle of sound enrichment is to provide supplementary<br>acoustic stimulation which can help defocus attention from tinnitus and avoid<br>negative reactions for both the subject and predicate device. The process of<br>providing tinnitus therapy occur a number of ways although the most popular<br>are Tinnitus Retraining Therapy (TRT) and Tinnitus Masking (TM). The<br>patient is then taken through a process of multiple protocols to set filter and<br>volume parameters via an onboard processing unit and an onboard digital<br>band pass filter to slowly assist in the habituation to the tinnitus. The Serenity<br>and predicate device are based on the following technological elements:<br>• Sound / Noise Filtering: Allows the spectral manipulation of the<br>sounds to a narrow band (frequency tuning) to occur at the time of<br>fitting.<br>• Volume Control: Can be adjusted with volume control by end user,<br>but limited by the hearing aid.<br>• Maximum Output Volume: Limited by hearing aid's Maximum Power<br>Output (MPO).<br>• Maximum Output Frequency: 10,000 Hz |
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| Substantial Equivalency<br>Information: | The following technological differences exist between the Serenity and predicate device: |
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| | Sound / Noise source: The Serenity and predicate device generated broad band complex sound and noise, respectively, at all frequencies across the frequency response. The frequency response is limited by hearing output (~10kHz). The usage of complex (non-noise) sounds that has been built into each sound utilized within the Serenity is consistent with scientific principles of effective sound therapy and does not raise any new issues of safety or efficacy. Sound / Noise level and shape: The “hearing loss” may vary from ear to ear the adjustments made provide customized amplification of the audio stream received by each hearing aid (frequency- and input-dependent output levels) shall be independent and according hearing loss as established in the hearing-aid fitting activity. Serenity device is determined for both ears simultaneously the custom levels are set for each ear hearing aid even in the case of asymmetrical hearing loss. Noise level and shape determined for both ears simultaneously. |

# VII. PERFORMACE DATA

| Biocompatibility: | The Sanuthera Serenity device works as a plug-in device to a commercially<br>available neck-worn bridge device and transmits the audio sounds through the<br>neck-worn device which wirelessly transmits the sounds to ear-level devices.<br>The Serenity device or commercially available neck-worn bridge device does<br>not have significant patient contact as the devices are typically worn over the<br>patient clothing. Therefore, the Serenity device does not present any<br>biocompatibility concerns.<br><br>The ear-level devices specifically utilized with the Sanuthera Serenity devices<br>are the Unitron's Moxi Kiss Behind-The-Ear (BTE) Family hearing aids. The<br>hearing aids are intended to be worn on or in the ear on a daily basis with a<br>typical duration of 8 – 12 hours continuously. The biocompatible properties<br>of the materials utilized in the Unitron's Moxi Kiss BTE Family hearing aids<br>were evaluated for the duration and type of contact as specified in ISO 10993-<br>1:2000/AC2010 – Biological Evaluation of Medical Devices. The battery of<br>testing include the following tests: |
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| Software Verification<br>and Validation Testing: | The software verification and validation testing were conducted and<br>documentation was provided as recommended by FDA's Guidance for<br>Industry and Staff, "Guidance for the Content of Premarket Submissions for<br>Software Contained in Medical Devices." The software for the Serenity<br>Tinnitus Masking Device was considered as a "minor" level of concern, since a<br>failure or latent flaw in the software could not directly result in a serious injury<br>or death to the patient or operator or lead to delay in delivery of appropriate<br>medical care that would likely lead to a minor injury. |
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| Animal Studies: | The Serenity Tinnitus Masking Device did not conduct any performance<br>testing on animals. |
| Clinical Studies: | The Serenity Tinnitus Masking Device did not conduct any clinical testing. |
| Risk and Warning for<br>Safe Use: | The Sanuthera's Serenity tinnitus masking device, being coupled to the uDirect<br>which sends the sounds wirelessly to the hearing aids, is limited to the settings<br>in the hearing aid's Maximum Power Output. According to OSHA<br>regulations, the volume of the Serenity's tinnitus masker can be set to a level<br>which could lead to permanent hearing damage when used for a prolonged<br>period of time. Should the tinnitus masker be set to such a level in your<br>hearing aid, your hearing healthcare professional will advise you of the<br>maximum amount of time per day you should use the tinnitus masker. The<br>tinnitus masker should never be used at uncomfortable levels.<br>According to OSHA (Occupational Safety & Health Administration, U.S.<br>Department of Labor) regulations, the maximum output of the tinnitus masker<br>feature can be set to a level that can lead to permanent hearing loss. The<br>maximum limit is 85 dBA SPL which corresponds to 8 hours daily use. |

#### CONCLUSION VII.

| Conclusion: | Based upon similar indications of use and technology characteristics it is<br>concluded the Sanuthera's Serenity to be substantially equivalent to K130494,<br>Unitron Tinnitus Masking feature. |
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