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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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