The HyperSound Timitus Module is indicated for patient home use in the temporary relief of tinnitus symptoms. The device is available in HyperSound Clear 500P audio systems to generate and deliver personalized sound output to timitus patients with or without hearing loss and with or without hearing aids. Any fitting of the device must be done by a hearing care professional. The target population is primarily adults (18 years or older).

Device Description

The HyperSound Tinnitus Module is a tool to a cleared device that provides the means to create personalized sound output to provide temporary relief to patients suffering from tinnitus. It is available as a firmware option embedded in the commercially available over the counter HyperSound Clear 500P system ("500P"), a Class II, 510(k)- cleared group hearing aid (K133352). The 500P consists of an amplifier and one or two emitters (directed audio speakers) and accompanying mains power supply.

Like the 500P, the HyperSound Tinnitus Module may be used by individuals with or without hearing loss and with or without hearing aids. As part of the prescription activation of the HyperSound Tinnitus Module option, a hearing care professional ("HCP") programs a Tinnitus EQ setting for the patient which may be a standard flat EQ or a custom EQ to fit to a patient's hearing loss and/or to shape frequency output to the user's tinnitus therapy preferences.

The activation and programming by the HCP is accomplished using the HyperFit fitting software tool only available to HCPs for use with the 500P. The user may select amongst relief sounds, fine-tune up to nine EQ bans to their liking and adjust common audio settings on the 500P device such as volume and balance (left and right speaker).

AI/ML Overview

The document provided describes the HyperSound Tinnitus Module, a device designed for the temporary relief of tinnitus symptoms.

Here's an analysis of the acceptance criteria and study data based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a tabulated format with specific pass/fail thresholds. Instead, it presents the results of a clinical study which effectively serves as the performance data to support the device's efficacy in achieving its intended use (temporary relief of tinnitus symptoms).

Acceptance Criteria (Implied from Study Objective)	Reported Device Performance (Summary of Clinical Study Results)
Reduction in perception of tinnitus loudness	Mean VAS-L scores decreased by 61% (from 59.6 to 23.5, p=0.000053)
Reduction in perception of tinnitus annoyance	Mean VAS-A scores decreased by 54% (from 64.3 to 29.5, p=0.00068)

Note: The "acceptance criteria" are inferred from the study's objective to "assess whether high-frequency directed audio... reduces the perception of tinnitus." The significant p-values indicate a statistically significant reduction.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size (Test Set): 11 adult patients
Data Provenance:
- Country of Origin: The study was conducted at the California Hearing and Balance Center in La Jolla, California, USA.
- Retrospective or Prospective: Prospective. It was a "pre and post-intervention clinical outcomes study" where subjects were exposed to the device after baseline measurements were established.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The "ground truth" in this context is the patient's subjective perception of tinnitus loudness and annoyance, measured by a validated Visual Analog Scale (VAS).

Number of Experts: The document mentions that subjects, in consultation with the Investigator (a HCP - Hearing Care Professional), selected and fine-tuned acoustic stimuli. The Investigator, a HCP, also tuned/shaped the device to the patient's audiogram. The study was conducted in a "controlled audiology clinical office."
Qualifications of Experts: The "Investigator" is identified as a "HCP" (Hearing Care Professional). No specific years of experience or further credentials (e.g., audiologist) are detailed, but the context implies a qualified professional in audiology.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The ground truth was established by direct patient self-report using a validated Visual Analog Scale (VAS) for loudness and annoyance. There was no independent expert adjudication of the patient's reported tinnitus perception. The Investigator's role was in fitting and customizing the device, not adjudicating the patient's subjective responses on the VAS. Therefore, the adjudication method was essentially none, relying on the patient's self-assessment.

5. 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

No, an MRMC comparative effectiveness study was not done. The device in question is a Tinnitus Module that generates sound for temporary relief, not an AI-powered diagnostic tool that assists human readers (e.g., radiologists) in interpreting medical images.
The study design was a pre- and post-intervention clinical outcomes study assessing the device's direct effect on patients' tinnitus perception.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, in essence, the "algorithm" performance was evaluated. The HyperSound Tinnitus Module itself, with its firmware and sound generation capabilities, is the core "algorithm." The study measured the direct effect of this module (when customized by a HCP and used by the patient) on tinnitus symptoms.
However, it's important to note the "human-in-the-loop" aspect during the initial setup and customization: "Any fitting of the device must be done by a hearing care professional." and "a hearing care professional ('HCP') programs a Tinnitus EQ setting for the patient." and "Subjects, in consultation with the Investigator (a HCP), selected from a choice of customized acoustic stimuli... The HyperSound 500P device was tuned or shaped by the Investigator... Subjects, with consultation from the Investigator, then fine-tuned (EQ) settings..." So, while the final delivery of sound is by the device, a HCP is essential for initial personalization.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth used was patient-reported outcomes data, specifically subjective perception of tinnitus loudness and annoyance, measured by a validated 100-point Visual Analog Scale (VAS-L and VAS-A).

8. The sample size for the training set

The document does not mention a separate training set for the HyperSound Tinnitus Module. The clinical study described is the primary performance evaluation, serving as the test set.
The device is a firmware option for an already cleared device (HyperSound Clear 500P). The "software verification and validation" section states that the firmware was verified and validated according to relevant standards, but no specific training data/set for an AI/machine learning model is described. The customization process by the HCP is done in real-time for each patient, not by a pre-trained model.

9. How the ground truth for the training set was established

As no training set is described for an AI/machine learning model, this question is not applicable based on the provided text. The device's operation relies on a HCP to personalize settings based on a patient's self-reported audiogram and tinnitus preferences.

Summary

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

August 23, 2016

Turtle Beach Corporation Mr. James A. Barnes VP Administration 12220 Scripps Summit Drive. Suite 100 San Diego, CA 92131

Re: K161331

Trade/Device Name: Hypersound Tinnitus Module Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus Masker Regulatory Class: Class II Product Code: KLW Dated: July 19, 2016 Received: July 21, 2016

Dear Mr. Barnes:

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 (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 (800) 638-2041 or (301) 796-7100 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 (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 -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) K161331

Device Name HyperSound Tinnitus Module

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary for the HyperSound Tinnitus Module 510(k) Number: K161331

Submitter:	Turtle Beach Corporation
Contact Person:	James A. Barnes, VP Administration
Date Prepared:	May 11, 2016
Device Name:	HyperSound Tinnitus Module
Device Class:	Class II
Classification Name:	Tinnitus Masker
Classification Regulation:	21 C.F.R. 874.3400
Product Code:	KLW
Predicate Devices:	K110932 GN Resound Tinnitus Sound GeneratorK111293 SoundCureTM SerenadeTM TinnitusTreatment System

INDICATION FOR USE

The HyperSound Tinnitus Module is indicated for patient home use in the temporary relief of tinnitus symptoms. The device is available in HyperSound Clear 500P audio systems to generate and deliver personalized sound output to tinnitus patients with or without hearing loss and with or without hearing aids. Any fitting of the device must be done by a hearing care professional. The target population is primarily adults (18 years or older).

DEVICE DESCRIPTION

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE

DEVICES

The HyperSound Tinnitus Module is a firmware functionality option to a cleared device. It has similar features as compared to the predicate devices, as indicated in the table below.

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	New	Predicate	Predicate
ManufacturerDevice Name	Turtle BeachHyperSound Tinnitus Module	GN ReSound A/STinnitus Sound Generator Module	SoundCure, Inc.SoundCure Serenade Tinnitus Treatment System
510(k)	K161331	K110932	K111293
Indications for Use	The HyperSound Tinnitus Module is indicated for patient home use in the temporary relief of tinnitus symptoms. The device is available in HyperSound Clear 500P audio systems to generate and deliver personalized sound output to tinnitus patients with or without hearing loss and with or without hearing aids. Any fitting of the device must be done by a hearing care professional.The target population is primarily adults (18 years or older).	The Tinnitus Sound Generator Module is a tool to generate sounds to be used in a Tinnitus Management Program to relieve patients suffering from tinnitus. The target population is primarily the adult population over 18 years of age. This product may also be used with children 5 years of age or older. The Tinnitus Sound Generator Module is targeted for healthcare professionals, which are treating patients suffering from tinnitus, as well as conventional hearing disorders. The fitting of the Tinnitus Sound Generator Module must be done by a hearing professional participating in a Tinnitus Management Program.	The SoundCure Serenade Tinnitus System is indicated for use in the temporary relief of tinnitus symptoms. The device is a tool to generate customized sounds to relieve patients suffering from tinnitus and can be used in a tinnitus management program.The target population is adults (18 years or older).This is a medical device and should only be used with the advice of a physician, audiologist or other hearing healthcare professional.
User Population	Adult population (18 years or older)	Adult population (>18 yrs)May also be used with children >5 yrs of age	Adult population (>18 yrs)
Where Used	Anywhere	Anywhere	Anywhere
Schedule of Use	All day	All day in all environments	All day
Mechanism of Action	Uses sound stimulus that can be frequency shaped and customized to the patient. Level of sound can be adjusted by a user volume control. Independent volume parameters per ear (inherent in the device through speaker balance control) Stimulus designed to be placed in the background and ignored	Uses noise that can be broad band to narrow band customized to the patient. Level of sound can be adjusted by a user volume control. Independent volume parameters per ear (inherent to ear specific device) Stimulus designed to be placed in the background and ignored	Uses noise that can be configured from broad band to narrow band, and pure tones customized to the patient. Level of sound can be adjusted by a user volume control. Independent volume parameters per ear Stimulus designed to be placed in the background and ignored
Technological Characteristics	Firmware functionality option embedded into a group hearing device.	Software module embedded into a digital hearing instrument.	Sounds encoded into a handheld device with earphones.
Maximum Output Characteristics	Maximum output hardware limited at 85dB SPL @ 1.5 kHz/1 meterResponse: 300 Hz to 22 kHz	Maximum output fixed at 93dB SPLOutput Frequency Response: Cutoffs at 500-6000 Hz	Maximum output fixed at 92dB SPLOutput Frequency Response: 1 kHz to 14 kHz
Design Features	Tinnitus Sound generator of tones and nature sounds with frequency shapingSounds customized to the patientOption to a directed audio group hearing aid	Tinnitus Sound Generator of tones and nature sounds with frequency shapingSounds customized to the patientOption to a behind the Ear hearing aid4 sound programs / tracks	Patient Device Sound Generator with frequency shaped soundsSounds customized to the patientHandheld device / earphones4 sound programs / tracks
Target Anatomy	Ear	Ear	Ear
Patient ContactMaterials	None	Silicone domes in openconfiguration	Silicone Earphones
Transducer	Directed audio speaker	Hearing aid transducer	Earphones
Power	External power supply (100-250VAC to 48V DC)	Battery, Hearing Aid Battery	Rechargeable Lithium-ionBatteryAlso includes external powersupply (100-250VAC to 5V DC)with power cord for recharging
Components	Firmware option embedded in500P directed audio system(amplifier, speakers andcabling) with external mainspower supply.500P User's GuideHyperSound 500P TinnitusModule User's Guide	Hearing AidUser Manual	SoundCure Serenade PatientDevice (audio player)EarphonesExternal power supply forrechargingUser's Manual
Meets ApplicableStandards testing	Yes	Yes	Yes

Comnarison Tahle

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The subject and predicate devices produce individually customizable sounds designed to provide masking relief to patients suffering from tinnitus. The subject is embedded firmware similar to GN ReSound A/S and like the Serenade device is not limited to users with hearing loss or listeners wearing aid. The addition of the tinnitus firmware module to the cleared 500P device does not affect the safety or effectiveness of the 500P device.

The subject device uses one or more directed audio speakers rather than a hearing aid or earbuds to deliver audio. There is no contact with the body or the ear and the device does not touch the patient during use. This technological difference does not present any new issues of safety or effectiveness.

PERFORMANCE DATA

Software Verification and Validation

The HyperSound Tinnitus Module is embedded firmware that has been verified and validated according to the relevant standards for medical device software and risk management procedures conducted and documented as recommended by FDA's Guidance for Industry and Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." All testing has demonstrated that the design of the HyperSound Tinnitus Module meets the established specifications necessary for consistent performance during its intended use.

The HCP HyperFit software tool is used to customize the Tinnitus Module and its application was verified and validated with commercialization of the 500P. The software for the HyperSound Tinnitus Module was considered as a "minor" level of concern, since a failure or latent flaw in the software could not directly result in serious injury or death to the patient or any operator or lead to delay in delivery of appropriate medical care that would likely lead to a minor injury. The output is limited by the 500P system and is less than the output of the predicate devices, which produce sound directly at the ear.

Clinical Study - HyperSound Tinnitus Support System

A clinical study was conducted by the California Hearing and Balance Center in La Jolla, California under a formal, written, Institutional Review Board (IRB) approved protocol. The clinical study was performed in a controlled audiology clinical office as a pre and post

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intervention clinical outcomes study using adult subjects with chronic, non- pulsatile tinnitus. This study is summarized as follows:

Objective: To assess whether high-frequency directed audio, using ultrasound technology, reduces the perception of tinnitus in subjects with chronic, non- pulsatile tinnitus. Study Design: Pre and post-intervention clinical outcomes study. Setting: Tertiary referral center.

Patients: Eleven adult patients with chronic, non-pulsatile tinnitus. Four subjects had unilateral chronic tinnitus and seven patients had bilateral chronic tinnitus. Intervention(s): After being exposed to a quiet environment for 5 minutes to establish baseline tinnitus, subjects completed a validated 100 point Visual Analog Scale (VAS) for tinnitus loudness (VAS-L) and annoyance (VAS-A). Subjects, in consultation with the Investigator (a HCP), selected from a choice of customized acoustic stimuli available to play on the HyperSound 500P. The HyperSound 500P device was tuned or shaped by the Investigator to the patient's audiogram using a standard fitting algorithm. Subjects, with consultation from the Investigator, then fine-tuned (EQ) settings to customize the frequency response of the HyperSound directed audio system output and adjusted volume to their personal preference. Subjects were then exposed (listened) to the selected and customized acoustic stimulus for duration of 60 minutes. After exposure, subjects again completed the Visual Analog Scale (VAS) for tinnitus loudness (VAS-L) and annoyance (VAS-A) to indicate the decree of annoyance and loudness while in the customized acoustic stimulus. Primary Outcome Measure: 100 point validated Visual Analog Scale (VAS) for tinnitus loudness (VAS-L) and annoyance (VAS-A).

Results: Highly significant reduction in tinnitus loudness and annoyance was observed in all subjects during exposure to a customized acoustic stimulus delivered with high frequency directed audio. The mean VAS-L scores decreased by 61% from a pre-exposure mean score of 59.6 to a post-exposure mean score of 23.5 (p=0.000053). The mean VAS-A scores decreased by 54% from a pre-exposure mean score of 64.3 to a post-exposure mean score of 29.5 (p=0.00068).

Conclusion: Delivery of a customized acoustic stimulus via high frequency directed audio using ultrasound technology demonstrated reduction in tinnitus loudness and annovance during exposure to the stimulus.

SUMMARY OF DATA

The HyperSound Tinnitus Module has been carefully compared to legally marketed devices with respect to intended use and technological characteristics. In addition, nonclinical testing was conducted to measure output and to validate the performance of the software and ensure the module performs as intended and meets the design specifications. The clinical performance information provides data on the masking relief of the HyperSound Tinnitus Module.

The performance testing and comparison to the predicate devices demonstrate that the HyperSound Tinnitus Module is substantially equivalent to the predicate devices and the delivery of masking sound through directed audio does not present any new issues of safety or effectiveness.

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.