TINNITUS SOUNDSUPPORT

K133308 · Oticon A/S · KLW · Mar 18, 2014 · Ear, Nose, Throat

Device Facts

• Record ID: K133308
• Device Name: TINNITUS SOUNDSUPPORT
• Applicant: Oticon A/S
• Product Code: KLW · Ear, Nose, Throat
• Decision Date: Mar 18, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Tinnitus SoundSupport is a tool intended to generate sounds to provide temporary relief to patients suffering from tinnitus as part of a tinnitus management program. The target population is the adult population (>18yrs). Tinnitus SoundSupport is targeted for licensed hearing care professionals (audiologists, hearing aid specialists, or otolaryngologists) who are familiar with the evaluation and treatment of tinnitus and hearing losses. The fitting of Tinnitus SoundSupport must be done by a hearing care professional participating in a tinnitus management program.

Device Story

Tinnitus SoundSupport is a software module embedded within digital wireless air conduction hearing instruments. It generates relief sounds (white, pink, or red noise) to provide temporary tinnitus relief. The device allows for frequency shaping via high-pass or low-pass filters, amplitude modulation, and volume control. It features automatic level steering. The device is operated by licensed hearing care professionals (audiologists, hearing aid specialists, or otolaryngologists) using Oticon fitting software to configure the sound output for the patient. The patient may adjust the volume when in use. The device is designed to comply with OSHA output limitation standards. By providing customizable sound therapy, it assists in tinnitus management programs, potentially benefiting patients by reducing the perceived burden of tinnitus.

Clinical Evidence

Bench testing only. The software module and fitting tool were verified and validated according to IEC 62304. Underlying hearing instruments were evaluated for EMC, electrical safety (IEC 60601-1, IEC 60601-1-2, IEC 60118-13), and biocompatibility (ISO 10993-1). No clinical data presented.

Technological Characteristics

Software module embedded in digital wireless air conduction hearing instruments. Features: white/pink/red noise generation, high/low pass filtering, amplitude modulation, volume control, automatic level steering. Compliance with OSHA output limits. Connectivity: wireless. Software lifecycle: IEC 62304.

Indications for Use

Indicated for adult patients (>18yrs) suffering from tinnitus, to be used as part of a tinnitus management program. Must be fitted by a licensed hearing care professional.

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, GnResound (K110932)
• Tinnitus Balance Software, Phonak (K123450)

Submission Summary (Full Text)

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## V133308 510(k) SUMMARY

#### Tinnitus SoundSupport

| Submitter: | Oticon A/S<br>Kongebakken 9<br>DK-2765 Smorum<br>Denmark<br>Phone: [phone]<br>Fax: [phone] | |
|----------------------------|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Contact Person: | Søren Juel Witt<br>Oticon A/S<br>Kongebakken 9<br>DK-2765 Smorum<br>Denmark<br>Mobile: [phone] | |
| Date Prepared: | 25. October 2013 | |
| Device Name: | Tinnitus SoundSupport | |
| Device Class: | Class II | |
| Classification Name: | Tinnitus Masker | |
| Classification Regulation: | 21 C.F.R. §874.3400 | |
| Product Code: | KLW | |
| Predicate Devices: | K110932<br>K123450 | Tinnitus Sound Generator, GnResound<br>Tinnitus Balance Software, Phonak |

#### Intended Use / Indications for Use

Tinnitus SoundSupport is a tool intended to generate sounds to provide temporary relief to patients suffering from tinnitus as part of a tinnitus management program.

The target population is the adult population (>18yrs).

Tinnitus SoundSupport is targeted for licensed hearing care professionals (audiologists, hearing aid specialists, or otolaryngologists) who are familiar with the evaluation and treatment of tinnitus and hearing losses. The fitting of

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Tinnitus SoundSupport must be done by a hearing care professional participating in a tinnitus management program.

## Technological Characteristics

- . Oticon's Tinnitus SoundSupport consists of a software module added to the company's class II, 510(k)-exempt wireless air conduction hearing instruments legally marketed under 21 C.F.R. 874.3305.
Tinnitus SoundSupport is fitted to the patient by the Hearing Care Professional using Oticon fitting software.

Tinnitus SoundSupport provides the option of relief sounds based on white, pink or red noise. The relief sounds can be limited in frequency by high pass or low pass filters. Tinnitus SoundSupport also provides the option of amplitude modulation, a volume control and automatic level steering.

The design of Tinnitus SoundSupport is based on the controls of the Occupational Safety and Health Administration (OSHA). Compliance with OSHA controls is achieved through (1) output limitation and (2) professional labeling and (3) patient labeling.

Tinnitus SoundSupport must be used as part of a tinnitus management program.

## Performance Data

Oticon's Tinnitus SoundSupport embedded software module and the Tinnitus tool in the fitting software has been verified and validated according to relevant standard for medical device software (Figure 7-1). In all instances, Oticon's Tinnitus SoundSupport functioned as intended and the performance observed was as expected.

| Standards No. | Standards Title |
|---------------|---------------------------------------------------------|
| IEC 62304 | Medical device software - Software life-cycle processes |
| Figure 7-1. | |

The underlying class II, 510(k)-exempt wireless air conduction hearing instruments marketed legally by Oticon under 21 C.F.R. 874.3305 has been evaluated according to relevant standards. This includes evaluation in accordance with standards relating to EMC and electrical safety as well as biocompatibility (Figure 7-2). In all instances, the 510(k)-exempt hearing instruments functioned as intended and the performance was as expected.

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| Standards No. | Standards Title |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ANSI C63.19-2007 | American National Standard Methods of Measurement of<br>Compatibility between Wireless Communications Devices and<br>Hearing Aids |
| IEC 60118-13 | Electroacoustics - Hearing aids - Part 13: Electromagnetic<br>compatibility (EMC) |
| IEC 60601-1-2:2007 +<br>Corrigendum 5/2010 | Medical electrical equipment - Part 1-2: General requirements<br>for basic safety and essential performance - Collateral<br>standard: Electromagnetic compatibility - Requirements and<br>tests |
| IEC 60601-1 | Medical electrical equipment - Part 1: General requirements for<br>basic safety and essential performance |
| ETSI 301 489-3 | Electromagnetic compatibility and Radio spectrum Matters<br>(ERM); ElectroMagnetic Compatibility (EMC) standard for radio<br>equipment and services; Part 3: Specific conditions for Short-<br>Range Devices (SRD) operating on frequencies between 9 kHz<br>and 40 GHz |
| ETSI 300 330-2 | Electromagnetic compatibility and Radio spectrum Matters<br>(ERM); Short Range Devices (SRD); Radio equipment in the<br>frequency range 9 kHz to 25 MHz and inductive loop systems in<br>the frequency range 9 kHz to 30 MHz Part 2: Harmonized EN<br>under article 3.2 of the R&TTE Directive |
| FCC 47 CFR Part 15<br>§15.109, §15.209, §15.223 | Title 47 of the Code of Federal Regulations; Chapter I<br>Part 15<br>- Radio frequency devices<br>- Radio frequency devices<br>Operation in the band 1.705-10 MHZ. |
| ISO 10993-1 | Biological evaluation of medical devices - Part 1: Evaluation<br>and testing within a risk management process |

Figure 7-2.

### Substantial equivalence

Oticon's Tinnitus SoundSupport is as safe and effective as GnResound's Tinnitus Sound Generator (K110932) and Phonak's Tinnitus Balance Software (K123450). As shown in the table below, Oticon's Tinnitus SoundSupport, GnResound's Tinnitus Sound Generator (K110932) and Phonak's Tinnitus Balance Software (K123450) have the same intended use and similar indications, technological characteristics and principles of operation. Minor technological differences do not present any new issues of safety or effectiveness. Thus, Oticon's Tinnitus SoundSupport is substantially equivalent to GnResound's Tinnitus Sound Generator (K110932) and Phonak's Tinnitus Balance Software (K123450).

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## Comparison table

## Oticon A/S.

## Tinnitus SoundSupport SUBSTANTIAL EQUIVALENCE CHART

| Device<br>Manufacturer | New | Predicate | Predicate |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Oticon | GN Resound | Phonak |
| 510(k) # | Tinnitus SoundSupport | Tinnitus Sound Generator | Tinnitus Balance software |
| | | K110932 | K123450 |
| Indications for use | Tinnitus SoundSupport is<br>a tool intended to<br>generate sounds to<br>provide temporary relief<br>to patients suffering from<br>tinnitus as part of a<br>tinnitus management<br>program.<br><br>The target population is<br>the adult population<br>(>18yrs).<br><br>Tinnitus SoundSupport is<br>targeted for licensed<br>hearing care<br>professionals<br>(audiologists, hearing aid<br>specialists, or<br>otolaryngologists) who<br>are familiar with the<br>evaluation and treatment<br>of tinnitus and hearing<br>losses. The fitting of<br>Tinnitus SoundSupport<br>must be done by a<br>hearing care professional<br>participating in a tinnitus<br>management program. | The Tinnitus Sound<br>Generator Module is a<br>tool to generate sounds<br>to be used in a Tinnitus<br>Management Program to<br>relieve patients suffering<br>from tinnitus.<br><br>The target population is<br>primarily the adult<br>population over 18 years<br>of age. This product may<br>also be used with<br>children 5 years of age or<br>older.<br><br>The Tinnitus Sound<br>Generator Module is<br>targeted for healthcare<br>professionals, which are<br>treating patients<br>suffering from tinnitus, as<br>well as conventional<br>hearing disorders.<br><br>The fitting of the Tinnitus<br>Sound Generator Module<br>must be done by a<br>hearing professional<br>participating in a Tinnitus<br>Management Program. | The target group for the<br>Phonak Tinnitus Balance<br>software feature are<br>adult 18 years of age or<br>older with tinnitus who<br>also desire amplification.<br><br>The Tinnitus Balance<br>software feature and<br>accompanying hearing<br>aid amplification is fit by<br>a licensed hearing<br>healthcare professional<br>(audiologist, hearing aid<br>specialist,<br>otolaryngologist) familiar<br>with the diagnosis and<br>management of tinnitus.<br>Phonak hearing aids<br>provide amplification to<br>address sensorineural,<br>conductive, or mixed<br>hearing losses.<br>Depending on the<br>specific model, Phonak<br>hearing aids cover fitting<br>range from mild to<br>profound hearing losses.<br><br>Before being fit with<br>Tinnitus Balance,<br>individuals presenting<br>with tinnitus should be<br>assessed by a licensed<br>ear physician to confirm |
| | | | |
| | | | the source of their |
| | | | tinnitus is not due to any |
| | | | of the following medical |
| | | | conditions: |
| | | | Visible congenital or<br>• |
| | | | traumatic deformity |
| | | | of the ear |
| | | | Any active drainage<br>• |
| | | | from the ear within |
| | | | the previous 90 days |
| | | | Sudden hearing loss<br>• |
| | | | within the previous |
| | | | 90 days |
| | | | Acute or chronic<br>• |
| | | | dizziness |
| | | | Unilateral hearing<br>• |
| | | | loss of sudden or |
| | | | recent onset within |
| | | | the previous 90 days |
| | | | Pain or discomfort in<br>• |
| | | | the ear |
| User population | Adult population (>18yrs) | Primarily adult population<br>(>18yrs), can be used for | Adult population (>18yrs) |
| | | patients >5yrs | |
| Schedule of use | All day | All day in all environments | Throughout the day |
| | Volume is set by HCP and | Volume is set by HCP and…