(277 days)
LiNX3D model hearing aid, Class II Exempt from 510(k) procedures
No
The document describes a software module for generating sounds for tinnitus relief and a remote fine-tuning feature. There is no mention of AI or ML algorithms being used for sound generation, fitting adjustments, or any other function. The adjustments are made by a healthcare professional or within limits set by them.
Yes.
The device is intended to temporarily relieve patients suffering from Tinnitus, which is a therapeutic purpose.
No
The device is described as a "Tinnitus Sound Generator Module" that generates sounds for temporary relief of tinnitus. It is a tool for managing a condition, not diagnosing it.
No
The device description explicitly states that the software solution is "embedded into a digital hearing instrument platform" and that the system verification includes "Different Hearing Instrument hardware with embedded software". This indicates the device includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Tinnitus Sound Generator Module generates sounds to temporarily relieve tinnitus. It is a therapeutic device, not a diagnostic one. It does not analyze any biological samples.
- Intended Use: The intended use is to generate sounds for a Tinnitus Management Program to provide temporary relief. This is a treatment/management function, not a diagnostic function.
- Device Description: The description details software embedded in a hearing instrument platform and a mobile app for adjusting settings. This aligns with a therapeutic device, not an IVD.
Therefore, the Tinnitus Sound Generator Module, as described, falls outside the scope of In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The Tinnitus Sound Generator Module is a tool to generate sounds to be used in a Tinnitus Management Program to temporarily 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.
Product codes (comma separated list FDA assigned to the subject device)
KLW
Device Description
The Tinnitus Sound Generator (TSG) Module provides a means for healthcare professionals to create a hearing instrument solution that provides temporary relief for Tinnitus patients. This software solution is embedded into a digital hearing instrument platform, so that the end-user (EU) can wear this device in all environments.
The fitting of the digital device, which contains the TSG Module, is performed by a healthcare professional, in order to meet the exact needs of the Tinnitus patient.
A mobile medical application (app) is available as an optional device to use with the TSG. The mobile medical app allows the user to adjust the hearing aid within the limits set by the healthcare professional during fitting of the hearing aid. The app is known as the TSG Tinnitus Manager app and is part of the Smart3D app.
The subject TSG Module has a new feature. i.e., Remote Fine-tuning (RFT) communication software (PC Interface software) that communicates with a healthcare professional's Fitting Software (FSW) via the user's Smart3D app and is part of the general software on the digital signal processor in GN's legally marketed, class II, 510(k) exempt Hearing Aids (Reference Device). The RFT communication software in the Reference device enables the healthcare professional to remotely adjust the Hearing Aid settings for these legally marketed, class II, 510(k) exempt Hearing Aids, including Hearing Aids that are compatible with the predicate TSG Module and the new TSG Module.
Similarly, the new TSG Module has a PC Interface Software modification that supports fine tuning of TSG Module settings from a remote location. The new TSG Module's PC Interface Software modification opens a bridge between the general RFT function on the Hearing Aid's digital signal processor and the TSG feature settings, that are also available for adjustments via the user's Smart3D app. Therefore, the RFT communication software part of the general software on the Hearing Aids containing the new TSG Module is also part of new TSG Module device.
The Health Care Professional (HCP) can make all of the same changes (Volume/loudness, Pitch/frequency. Nature sounds, and Amplitude modulation) that the user can make. Additionally, the HCP can turn the TSG/tinnitus masker on or off and can set and adjust the Volume Control range and environmental steering sounds. The TSG Volume Control range feature is available only to the HCP. This feature allows the HCP to set a limit on the TSG volume range an EU can adjust. This feature is specifically designed for the safety of the EU, ensuring that an EU cannot increase the TSG volume above a level determined appropriate by the HCP. The system can in no case exceed 100dB SPL for TSG. The TSG Volume Control range has a range of +12dB to -6dB from the TSG fitting by the HCP and can be found in the FSW under the Fitting / Manual Controls / Volume Control Range. For example, if the HCP sets the TSG Volume Control range to +6dB to -6dB, this means an EU cannot set the TSG volume more than 6dB above or below the initial fitting.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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.
Intended User / Care Setting
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 RFT feature will only be used under clinical supervision from 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
GN Hearing has conducted a risk analysis and has performed the necessary verification and validation activities to demonstrate that the design outputs of the modified device meet the design input requirements.
Besides the detailed verification of all requirements, the TSG Module is verified in an integrated system verification test. The integrated system consists of:
- Different Hearing Instrument hardware with embedded software, including the TSG Module.
- App (iOS & Android)
- Fitting Software (FSW) .
The system verification includes system end-to-end testing and interoperability performance testing. The result of the system verification show that test has passed with no defects critical for function, form, intended use, or pose any user risks.
The successful validation activities conducted for the subject device are based on experience with similar validation activities for the predicate device and reference device.
The successful validation activities related to the RFT feature were conducted to show that human factors and usability are safe and effective.
The system verification outcome, together with the TSG Module verification and validation outcome, supports substantial equivalence of the subject device compared to the Predicate Device, verified and validated under similar conditions at GN Hearing.
The system verification outcome, together with the TSG Module verification and validation outcome, also supports substantial equivalence of the RFT Feature in the subject device compared to the predicate device, showing that RFT is safe and effective.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
LiNX3D model hearing aid, Class II Exempt from 510(k) procedures
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and full name on the right. The Department of Health and Human Services logo is a stylized depiction of a human figure embracing a sphere. The FDA acronym is in a blue square, and the full name, "U.S. Food & Drug Administration," is in blue text.
November 30, 2018
GN Hearing A/S Lars Hagander Vice President Corporate Quality Lautrupbjerg 7 DK-2750 Ballerup, Denmark
Re: K180495
Trade/Device Name: Tinnitus Sound Generator Module Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus Masker Regulatory Class: Class II Product Code: KLW Dated: October 30, 2018 Received: November 2, 2018
Dear Lars Hagander:
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. Although this letter refers to your product as a device. please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
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
2
| | DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| | Indications for Use | Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below. |
| 510(k) Number (if known) | K180495 | |
| Device Name | Tinnitus Sound Generator Module | |
| Indications for Use (Describe) | The Tinnitus Sound Generator Module is a tool to generate sounds to be used in a Tinnitus Management Program to
temporarily 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. | |
| 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
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"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."
FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
3
510(k) SUMMARY
| Submission Type: | Traditional 510(k) |
|---|---|
| Submitter: | GN Hearing A/S |
| Lars Hagander | |
| Lautrupbjerg 7 | |
| DK-2750 Ballerup | |
| Denmark | |
| Phone: +45 45 75 11 11 | |
| Registration number: 3005650109 | |
| Date Prepared: | November 28, 2018 |
| Device Name: | Tinnitus Sound Generator Module |
| Device Class: | Class II |
| Classification Name: | 21 CFR 874.3400 Tinnitus masker |
| Classification Panel: | Ophthalmic and Ear, Nose, and Throat Division |
| Product Code: | KLW |
| Predicate Device: | Tinnitus Sound Generator Module, K181586 |
| Reference Device : | LiNX3D model hearing aid, Class II Exempt from 510(k) |
| procedures |
Device Description
The Tinnitus Sound Generator (TSG) Module provides a means for healthcare professionals to create a hearing instrument solution that provides temporary relief for Tinnitus patients. This software solution is embedded into a digital hearing instrument platform, so that the end-user (EU) can wear this device in all environments.
The fitting of the digital device, which contains the TSG Module, is performed by a healthcare professional, in order to meet the exact needs of the Tinnitus patient.
A mobile medical application (app) is available as an optional device to use with the TSG. The mobile medical app allows the user to adjust the hearing aid within the limits set by the healthcare professional during fitting of the hearing aid. The app is known as the TSG Tinnitus Manager app and is part of the Smart3D app.
4
The subject TSG Module has a new feature. i.e., Remote Fine-tuning (RFT) communication software (PC Interface software) that communicates with a healthcare professional's Fitting Software (FSW) via the user's Smart3D app and is part of the general software on the digital signal processor in GN's legally marketed, class II, 510(k) exempt Hearing Aids (Reference Device). The RFT communication software in the Reference device enables the healthcare professional to remotely adjust the Hearing Aid settings for these legally marketed, class II, 510(k) exempt Hearing Aids, including Hearing Aids that are compatible with the predicate TSG Module and the new TSG Module.
Similarly, the new TSG Module has a PC Interface Software modification that supports fine tuning of TSG Module settings from a remote location. The new TSG Module's PC Interface Software modification opens a bridge between the general RFT function on the Hearing Aid's digital signal processor and the TSG feature settings, that are also available for adjustments via the user's Smart3D app. Therefore, the RFT communication software part of the general software on the Hearing Aids containing the new TSG Module is also part of new TSG Module device.
The Health Care Professional (HCP) can make all of the same changes (Volume/loudness, Pitch/frequency. Nature sounds, and Amplitude modulation) that the user can make. Additionally, the HCP can turn the TSG/tinnitus masker on or off and can set and adjust the Volume Control range and environmental steering sounds. The TSG Volume Control range feature is available only to the HCP. This feature allows the HCP to set a limit on the TSG volume range an EU can adjust. This feature is specifically designed for the safety of the EU, ensuring that an EU cannot increase the TSG volume above a level determined appropriate by the HCP. The system can in no case exceed 100dB SPL for TSG. The TSG Volume Control range has a range of +12dB to -6dB from the TSG fitting by the HCP and can be found in the FSW under the Fitting / Manual Controls / Volume Control Range. For example, if the HCP sets the TSG Volume Control range to +6dB to -6dB, this means an EU cannot set the TSG volume more than 6dB above or below the initial fitting.
Intended Use
The Tinnitus Sound Generator Module is a tool to generate sounds to be used in a Tinnitus Management Program to temporarily 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.
Indications for Use statement
The Tinnitus Sound Generator Module is a tool to generate sounds to be used in a Tinnitus Management Program to temporarily 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 Tinnitus Sound Generator module must be done by a hearing professional participating in a Tinnitus Management Program.
The Indications for Use Statement for the new device is not identical to that of the predicate device in that the word "temporarily" is added to clarify relief from Tinnitus provided by the new TSG Module is
5
temporary. This minor modification does not impact safety or effectiveness and both the new and predicate devices have the same intended use.
Comparison of Technological Characteristics with the Predicate Device
All of the new device's technological characteristics are identical to those of the predicate device except for one modification: the addition of Support for RFT. which is a PC Interface Software modification that supports fine tuning from a remote location of each of the TSG Module's settings that can be adjusted by the EU (or parent or guardian in the case of a minor) and/or the HCP using the FSW in the clinic.
The subject TSG Module's new RFT communication software communicates with a healthcare professional's FSW via the user's Smart3D app and is part of the general software on the digital signal processor in GN's legally marketed, class II, 510(k) exempt Hearing Aids (Reference Device). The RFT communication software in the Reference device enables the healthcare professional to remotely adjust the Hearing Aid settings for these legally marketed, class II, 510(k) exempt Hearing Aids, including Hearing Aids that are compatible with the predicate and new TSG modules.
Similarly, the new TSG Module's PC Interface Software modification supports fine tuning of TSG Module's settings from a remote location. The predicate TSG module device does not contain a RFT feature to adjust its parameters from a remote location.
The TSG Module's PC Interface Software modification opens a bridge between the general RFT function on the Hearing Aid's digital signal processor and the TSG Module's parameter settings that are also available for adjustments via the EU's Smart3D app. Therefore, the RFT communication software part of the general software on the Hearing Aids containing the new TSG Module's is also part of new TSG Module.
The new RFT feature is only enabled by the healthcare professional if the healthcare professional finds it feasible, based on an initial in-office assessment of the EU.
The app requires the EU, or the parent or legal guardian in cases where the user is a minor, to answer an inventory of questions to better understand the EU's need for the new RFT request is sent to the healthcare professional. Based on the request, and a clinical judgement, the healthcare professional will send the fine-tuned settings to the EU. If the healthcare professional feels the request is against their best clinical judgement, or 'out of the ordinary', the healthcare professional should first request a face-to-face/live follow-up visit (e.g., phone call, clinical visit) prior to making any changes via RFT. The EU, or the parent or legal guardian in cases where the user is a minor, is required to accept the changes.
This one modification to the technological characteristics of the new device, i.e., the addition of Support for RFT, which is a PC Interface Software modification, has minimal risk to the patient and based on the risk analysis, all risks have been mitigated to an acceptable level. The combined minor differences between the Indications for Use (the addition of the word "temporarily") and the single technological change (the addition of Support for RFT for the adjustable parameters of the TSG Module) are minor modifications in relation to the predicate device that do not change the operating principle of the TSG module.
6
Performance Data
GN Hearing has conducted a risk analysis and has performed the necessary verification and validation activities to demonstrate that the design outputs of the modified device meet the design input requirements.
Besides the detailed verification of all requirements, the TSG Module is verified in an integrated system verification test. The integrated system consists of:
- Different Hearing Instrument hardware with embedded software, including the TSG Module. ●
- . App (iOS & Android)
- Fitting Software (FSW) .
The system verification includes system end-to-end testing and interoperability performance testing. The result of the system verification show that test has passed with no defects critical for function, form, intended use, or pose any user risks.
The successful validation activities conducted for the subject device are based on experience with similar validation activities for the predicate device and reference device.
The successful validation activities related to the RFT feature were conducted to show that human factors and usability are safe and effective.
7
| 21 CFR 874.3305
Special controls | Reference device LiNX3D | Remote Fine Tuning part of
LiNX3D |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| (1) Appropriate
analysis/testing
should validate
electromagnetic
compatibility (EMC)
and safety of
exposure to non-
ionizing radiation | EMC testing was done in
accordance to the appropriate
standards IEC 60601-1-2 and IEC
60118-13.
EMF assessment was done in
accordance to IEC 62311 and IEC
62479.
The tests and the assessment were
performed by the accredited test
house:
DEKRA Testing and Certification,
S.A.U. Parque Tecnológico de
Andalucía, c/ Severo Ochoa nº 2,
29590 Campanillas, Málaga, Spain.
Test reports demonstrate compliance
to the FDA medical device recognized
standards, and the regulatory radio
requirements in relation to the US
Federal Communications Commission
(FCC). The testing and the assessment
demonstrate that the implemented
wireless technology is safe. | The RFT feature does not operate
using a different technology than
the other wireless hearing aid
features. |
| (2) Design,
description, and
performance data
should validate
wireless technology
functions | The design controls activities for the
LiNX3D hearing aid are identical to the
activities described in Annex IX of the
K180495 submission. The GN Hearing
New Product Development process
#0216640 were followed.
The wireless technology was developed
and documented as part of this process
and performance data in the form of
verification of all wireless technology
requirements | The RFT feature does not operate
using a different wireless
technology than the other
wireless hearing aid features.
The features using the wireless
technology in relation to RFT
were verified and validated to be
safe and effective as part of the
design process. |
The reference device, LiNX3D hearing aid, meets the special controls identified in 21 CFR 874.3305:
8
| (3) Labeling should
specify appropriate
instructions, warnings,
and information
relating to EMC and
wireless technology
and human exposure
to non-ionizing
radiation | Risk controls related to wireless
technology, identified as part of the Risk
Management, include labeling
requirements with appropriate
instructions, warnings, and information
related to EMC and wireless technology
and human exposure to non-ionizing
radiation.
The user guide informs the user about
the device containing a RF transmitter
operating wireless, and the precautions
related to that, like coexistence with
other devices, flight mode, etc. | RFT uses the same wireless
technology for communication as
the standard hearing aid
functionalities. No additional
labeling required. |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
The system verification outcome, together with the TSG Module verification and validation outcome, supports substantial equivalence of the subject device compared to the Predicate Device, verified and validated under similar conditions at GN Hearing.
The system verification outcome, together with the TSG Module verification and validation outcome, also supports substantial equivalence of the RFT Feature in the subject device compared to the predicate device, showing that RFT is safe and effective.
Precautions
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. However, children and physically or mentally challenged users will require training by a doctor, audiologists, hearing care practitioner or the guardian for the insertion and removal of the device containing the TSG module.
Children and physically or mentally challenged users will require guardian supervision while wearing the device.
The volume control is a feature in the TSG module used for adjusting the sound generator output level. To prevent unintended usage by pediatric or physically or mentally challenged users, the volume control must be configured to only provide a decrease of the sound generator output level.
Adjustment of the tinnitus sound generator settings, using a smartphone app, should only be performed by the parent or legal guardian in cases where the user is a minor.
Use of the ReSound Assist for remote settings of the tinnitus sound generator, should only be performed by the parent or legal guardian in cases where the user is minor
The RFT feature will only be used under clinical supervision from a Hearing Care Professional. Initial fitting must be done face-to-face in the office of the hearing care professional and RFT should only be used for follow-up adjustments.
9
The user is informed to discontinue use of the sound generator and consult promptly with a licensed physician if they experience one of the following conditions:
- a. Visible congenital or traumatic deformity of the ear.
- b. History of active drainage from the ear within the previous 90 days.
- c. History of sudden or rapidly progressive hearing loss within the previous 90 days.
- d. Acute or chronic dizziness.
- e. Unilateral hearing loss of sudden or recent onset within the previous 90 days.
- f. Visible evidence of significant cerumen accumulation or a foreign body in the ear canal.
- g. Pain or discomfort in the ear.
The user is also informed to discontinue use of the sound generator and consult promptly with the hearing care professional if they experience changes in the tinnitus perception, discomfort or interrupted speech perception, while using the tinnitus sound generator.
Conclusions
The single minor modification to the Indications for Use statement and the one minor modification to the technological characteristics of the new device do not raise new or different questions of safety or effectiveness as compared to the predicate device. The results of risk analysis and design verification and validation activities provide evidence that the new device is as safe and effective as its predicate and therefore, demonstrate that the TSG Module is substantially equivalent to the predicate device.