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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.

• 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.

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The 1E-Zen program is intended to provide a relaxing sound background for adults (21 years and older) who desire to listen to such a background in quiet. It may be used as a sound therapy tool in a tinnitus treatment program that is programmed by a licensed hearing healthcare professional (audiologists, hearing aid specialists, otolaryngologists) who is trained in tinnitus management.

The IE-Zen program is intended to be used in quiet where hearing everyday sounds is not critical.

The CLEAR series hearing aids (including CLEAR440. CLEAR330. CLEAR220 and super-power SUPER440 and SUPER220 - also privately labeled as REVIVE700. REVIVE640, REVIVE630, REVIVE707 and REVIVE637) are digital wireless air conduction hearing aids all using the WidexLink radio. The different series represent different price points for the CLEAR hearing aids (see discussion of difference in application). The WidexLink is a low power proprietary radio, which enables communication between hearing aids and from other peripheral units. We have two units which can communicate with the CLEAR hearing aids: a simple remote control (RC-DEX) which can change volume and program in the hearing aid and a programming unit (TM-DEX) which is used in combination with a universal programming interface nEARcom/NoahLink programming system. A detailed description of the WidexLink platform is available in the 510K application (K101699).

The added feature to the approved CLEAR440 hearing aid is the optional inter-ear Zen (IE-Zen) feature. Wireless is used in the IE-Zen to identify if the Zen program is used in a monaural mode or binaural mode. The IE-Zen is a tool that generates and delivers a relaxing sound background. It may also be used as a sound source to distract and/or mask tinnitus in tinnitus sufferers. A broadband noise and 5 melodic tone patterns that are generated using fractal mathematics can be selected as Zen programs. The clinician can adjust the characteristics (intensity, pitch and tempo) of each program and the patient can retrieve up to 3 programs with the touch of a program button. The IE-Zen can be used with or without amplification.

Here's an analysis of the acceptance criteria and supporting study for the Widex IE-Zen Program, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state formal, quantitative acceptance criteria for the IE-Zen program. Instead, it relies on comparative equivalence to a predicate device and positive user feedback. However, we can infer some implied criteria and list the corresponding performance as reported.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The text states, "A study on the acceptability of the IE-Zen tones to hearing impaired people showed that the majority of listeners (80%)." While it refers to "hearing impaired people" and "listeners," a specific numerical sample size (e.g., N=X) for this acceptability study is not provided.
• Data Provenance: The document does not explicitly state the country of origin for the acceptability study. It mentions an "independent study conducted at UCSF" for the predicate Zen tones' effectiveness in reducing tinnitus severity, implying the U.S. for that specific study. The nature (retrospective or prospective) of the acceptability study is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• This information is not provided in the document. The acceptability study relies on subjective listener ratings, not expert-established ground truth in the traditional sense of medical image or diagnosis evaluation. The "ground truth" here is the individual's subjective experience of "relaxing."

4. Adjudication Method for the Test Set

• This information is not applicable/provided. Since the "ground truth" is individual listener perception of "relaxing," there is no mention of an adjudication process among experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted as described for human readers improving with AI vs. without AI assistance. This device is not an AI diagnostic tool and doesn't involve human readers interpreting AI output. The study focused on the acceptability and preference of the IE-Zen tones by individuals.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Yes, in essence. The acceptability study evaluates the performance of the IE-Zen program itself (the algorithm generating the tones) as perceived by listeners, without explicitly involving real-time human intervention in the tone generation or modification during the test. The device generates the sounds, and the user experiences them.

7. Type of Ground Truth Used

• Subjective User Feedback/Self-Reported Experience: For the acceptability study, the "ground truth" was the subjective rating by hearing-impaired individuals themselves as to whether the tones were "somewhat relaxing" or "very relaxing."
• Clinical Efficacy (for predicate device, inferred for IE-Zen): For the predicate Zen tones, the ground truth for effectiveness was reduction in tinnitus severity, presumably measured through patient self-report questionnaires or clinical assessments (though the exact method from the UCSF study is not detailed here).

8. Sample Size for the Training Set

• This information is not provided and is likely not relevant as the IE-Zen program is described as generating tones based on fractal mathematics and clinician adjustments, rather than being a deep learning model trained on a large dataset. No training set is mentioned for the development of the tone-generation logic itself.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As the text does not describe an AI training process with a specific training set or ground truth in the context of machine learning, this question does not apply to the information presented. The device's functionality is based on predefined algorithms and user-adjustable parameters.

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