(103 days)
Not Found
No
The description focuses on personalized sound output based on professional programming and user adjustments, with no mention of AI or ML algorithms for analysis or adaptation.
Yes
The device is indicated for "temporary relief of tinnitus symptoms," which is a claim of therapy.
No
The device is indicated for temporary relief of tinnitus symptoms and provides personalized sound output; it does not diagnose any conditions or disease states.
No
The device is described as a "firmware option embedded in the commercially available over the counter HyperSound Clear 500P system," which is a hardware device consisting of an amplifier and emitters (speakers). While the Tinnitus Module itself is software/firmware, it is inextricably linked to and functions within a specific hardware system, making the overall medical device a combination of hardware and software, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "temporary relief of tinnitus symptoms" by generating and delivering personalized sound output. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is described as a "tool to a cleared device that provides the means to create personalized sound output." It's a firmware option embedded in a hearing aid system. This aligns with a therapeutic or assistive device, not a diagnostic test.
- Lack of Diagnostic Function: There is no mention of the device analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis. IVDs are designed to diagnose diseases or conditions.
- Anatomical Site: The anatomical site is the ear, which is consistent with a device that delivers sound for therapeutic purposes related to hearing or tinnitus.
- Performance Studies: The performance studies focus on the reduction of tinnitus loudness and annoyance, which are measures of therapeutic effectiveness, not diagnostic accuracy.
In summary, the HyperSound Tinnitus Module is a therapeutic device designed to alleviate symptoms, not an in vitro diagnostic device used to diagnose a condition.
N/A
Intended Use / Indications for Use
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).
Product codes
KLW
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear
Indicated Patient Age Range
Adult population (18 years or older)
Intended User / Care Setting
Home use for patients, with fitting done by a hearing care professional.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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-intervention clinical outcomes study using adult subjects with chronic, non-pulsatile tinnitus.
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.
Key Metrics
VAS-L (tinnitus loudness) and VAS-A (tinnitus annoyance) scores.
Mean VAS-L scores decreased by 61% from 59.6 to 23.5 (p=0.000053).
Mean VAS-A scores decreased by 54% from 64.3 to 29.5 (p=0.00068).
Predicate Device(s)
K110932 GN Resound Tinnitus Sound Generator, K111293 SoundCureTM SerenadeTM Tinnitus Treatment System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 an abstract symbol that resembles a stylized caduceus or a series of interconnected human profiles.
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.
1
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
2
Indications for Use
510(k) Number (if known) K161331
Device Name HyperSound Tinnitus Module
Indications for Use (Describe)
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).
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 Generator |
| K111293 SoundCureTM SerenadeTM Tinnitus | |
| Treatment 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
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).
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.
4
| New | Predicate | Predicate | |
|---|---|---|---|
| Manufacturer | |||
| Device Name | Turtle Beach | ||
| HyperSound Tinnitus Module | GN ReSound A/S | ||
| Tinnitus 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 meter
Response: 300 Hz to 22 kHz | Maximum output fixed at 93dB SPL
Output Frequency Response: Cutoffs at 500-6000 Hz | Maximum output fixed at 92dB SPL
Output Frequency Response: 1 kHz to 14 kHz |
| Design Features | Tinnitus Sound generator of tones and nature sounds with frequency shaping
Sounds customized to the patient
Option to a directed audio group hearing aid | Tinnitus Sound Generator of tones and nature sounds with frequency shaping
Sounds customized to the patient
Option to a behind the Ear hearing aid
4 sound programs / tracks | Patient Device Sound Generator with frequency shaped sounds
Sounds customized to the patient
Handheld device / earphones
4 sound programs / tracks |
| Target Anatomy | Ear | Ear | Ear |
| Patient Contact
Materials | None | Silicone domes in open
configuration | 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-ion
Battery
Also includes external power
supply (100-250VAC to 5V DC)
with power cord for recharging |
| Components | Firmware option embedded in
500P directed audio system
(amplifier, speakers and
cabling) with external mains
power supply.
500P User's Guide
HyperSound 500P Tinnitus
Module User's Guide | Hearing Aid
User Manual | SoundCure Serenade Patient
Device (audio player)
Earphones
External power supply for
recharging
User's Manual |
| Meets Applicable
Standards testing | Yes | Yes | Yes |
Comnarison Tahle
5
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
6
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.