(274 days)
The Hansaton Tinnitus Maskers are air conduction broad band noise generators and hearing aids intended to output noise of sufficient intensity and bandwidth to be used for tinnitus habituation therapy and are suitable for tinnitus masking therapy. Optional, the Hansaton SOUL Tinnitus Maskers provide amplification, intended to be used by those individuals who experience tinnitus and desire amplification. Diagnosis and prescription of the tinnitus maskers must be performed by hearing health specialists (e.g., ENT specialists, audiologists, or hearing system professionals) who are experienced in tinnitus management.
The target population is primarily the adult population over 18 years of age. The instruments are not intended for pediatric use.
The Hansaton Tinnitus Maskers are provided in two versions; the WAVE 2G, a noise generator intended to output noise for tinnitus habituation therapy and tinnitus masking therapy, and SOUL, a noise generator and hearing aid additionally providing amplification. Both, the WAVE 2G and the SOUL, systems are available as 'In The Ear' (ITE) and 'Behind The Ear' (BTE) versions.
The provided document is a 510(k) Summary for Hansaton Tinnitus Maskers (WAVE 2G and SOUL). It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study specifically designed to establish performance against those criteria.
Therefore, the requested information elements related to specific acceptance criteria, a standalone study to prove performance against those criteria, sample sizes for test and training sets, expert consensus for ground truth, and MRMC studies are not explicitly present in this type of regulatory submission.
However, I can extract and infer the closest relevant information from the document as follows:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present a table of specific acceptance criteria (e.g., specific accuracy metrics, sensitivity, specificity, etc.) for the device's clinical performance. Instead, it relies on demonstrating substantial equivalence to existing legally marketed predicate devices. The "reported device performance" is primarily characterized by its electroacoustical characteristics and biocompatibility, as evaluated against established standards for hearing aids.
| Category | Acceptance Criteria (Inferred from standards and predicate devices) | Reported Device Performance (as stated or implied) |
|---|---|---|
| Intended Use | Must be substantially equivalent to predicate devices for tinnitus habituation therapy, tinnitus masking therapy, and optional amplification. | - WAVE 2G: Noise generator for tinnitus habituation therapy and tinnitus masking therapy. |
- SOUL: Noise generator and hearing aid for tinnitus habituation therapy, tinnitus masking therapy, and amplification for those experiencing tinnitus and desiring amplification.
- Target population: Adults over 18. |
| Technological Characteristics | Must be substantially equivalent to predicate devices (e.g., digital circuit type, programmability, multiple programs, available noises, volume control, physical description, RMS output characteristics). | WAVE 2G: Digital, Programmable (Yes), Multiple programs (Yes, except Cymba), Four available noises, Volume control (Yes), Eight channels, Available as standard BTE (X-Mini and Slim) and ITE (Mini Canal and Cymba), RMS output (Noiser): 70-90 dB (device dependent).
SOUL: Digital, Programmable (Yes), Multiple programs (Yes, except Cymba), Four available noises, Volume control (Yes), 8/4 or 12/12 channels (Economy/Business), Available as standard BTE and ITE, RMS output (Noiser): 65-85 dB (device dependent), RMS output (Hearing aid amplifier) up to 116 dB HF-Average OSPL 90. |
| Safety | Must comply with biocompatibility standards (ISO 10993). Must not introduce new potential hazards or safety risks compared to predicates. | All patient contacting materials evaluated in terms of biocompatibility in accordance with the ISO 10993 standard series. |
| Electoacoustical Performance | Must comply with IEC 60118 series standards for hearing aids. | Developed and tested in accordance with IEC 60118-0, -1, -2, -6, -13. (Specific values are listed under "RMS output characteristics" in the comparison table with predicate devices, suggesting compliance with performance envelopes of predicates and standards). |
| Speech Test | Implied compliance with "Nordic Requirements 7th edition appendix A." | A speech test performed in accordance with the Nordic Requirements 7th edition appendix A. (No specific outcomes reported, only that it was performed.) |
2. Sample size used for the test set and the data provenance
Not applicable. This is not a study involving patient data for a test set. The performance testing refers to engineering and quality assurance tests on the devices themselves against established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No "ground truth" for clinical performance on a test set is established by experts in this type of submission.
4. Adjudication method for the test set
Not applicable.
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
Not applicable. This device is not an AI-powered diagnostic tool. It is a tinnitus masker and hearing aid.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm. Its performance is evaluated intrinsically (electroacoustical characteristics) and for safety (biocompatibility).
7. The type of ground truth used
The "ground truth" in this context refers to established engineering standards (IEC 60118 series) for electroacoustical performance and biocompatibility standards (ISO 10993) for patient-contacting materials. The comparison is also made against the specifications and performance of legally marketed predicate devices.
8. The sample size for the training set
Not applicable. This device is not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.