Search Results
Found 1 results
510(k) Data Aggregation
(85 days)
The 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 prescribed by a licensed hearing healthcare professional (audiologists, hearing aid specialists, otolaryngologists) who is trained in tinnitus management.
The Zen program is intended to be used in quiet where hearing everyday sounds is not critical.
The Zen program is an optional listening program within the Widex Mind 440 digital hearing aid family. It 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 as many as 4 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 Zen can be used with or without amplification.
The Widex Zen program, an optional listening program within the Mind 440 digital hearing aid family, generates and delivers a relaxing sound background. It can also be used as a sound source to distract and/or mask tinnitus in tinnitus sufferers.
Here's an analysis of the acceptance criteria and the study that supports it:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Effectiveness for Relaxing Sound Background: | "the majority of listeners (85%) rated the Zen tones as ‘somewhat relaxing' or ‘very relaxing.'" |
| Effectiveness for Tinnitus Management: | Expected to be "just as effective as the predicate devices" (K043274 Neuromonics Tinnitus Treatment, K011366 Siemens Custom TCI-Combi, K974501 Digital tinnitus masking system). |
| Safety: | "no more risk to the use of the Zen program than the use of conventional hearing aids and/or tinnitus masker." The safety of the hearing aid is "unaltered." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "A study on the acceptability of the Zen tones to hearing impaired people showed that the majority of listeners (85%) rated the Zen tones as 'somewhat relaxing' or 'very relaxing.'" The exact numerical sample size for this acceptability study is not provided.
- Data Provenance: Not explicitly stated, but given the manufacturer (Widex A/S, Denmark) and the contact person's location in the US (Illinois), it could be either a European or US study. The document does not specify if the study was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- For the acceptability study, the "ground truth" was based on subjective ratings ("somewhat relaxing" or "very relaxing") from hearing-impaired individuals. There is no mention of experts establishing ground truth for this particular finding.
- For the tinnitus management aspect, the claim of effectiveness is based on substantial equivalence to predicate devices, rather than a new study with expert-established ground truth.
4. Adjudication Method for the Test Set
- Not applicable as the reported data for the acceptability study relies on individual participant ratings, not expert adjudication of a test set. For the tinnitus management claim, it's based on equivalence to predicate devices, not a separate adjudication process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
- No MRMC comparative effectiveness study was mentioned or performed. The device is a sound-generating program within a hearing aid, not an AI diagnostic tool that assists human readers with interpretations. Therefore, the concept of "human readers improve with AI vs without AI" is not applicable here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, for the "acceptability of the Zen tones," the performance was evaluated based on direct feedback from users, which can be considered standalone performance in terms of the device's ability to generate tones rated as relaxing.
- For the tinnitus management claim, the "standalone" performance is inferred through substantial equivalence to other devices that operate without continuous human intervention during their primary function (sound generation/masking).
7. The Type of Ground Truth Used
- For the reported acceptability data: Subjective user experience/perception ("somewhat relaxing" or "very relaxing") served as the ground truth.
- For the tinnitus management claim: Equivalence to the demonstrated effectiveness of predicate devices that serve similar functions. There is no new "ground truth" established for tinnitus relief in this specific submission.
8. The Sample Size for the Training Set
- Not applicable / not provided. The Zen program is described as generating "fractal mathematics" patterns and broadband noise. This implies a rule-based or algorithmically generated system rather than a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As the device's sound generation mechanism is likely based on mathematical algorithms and digital synthesis rather than machine learning, there would be no "training set" or corresponding ground truth establishment in the conventional sense of AI/ML development. The design principles for the "relaxing sound background" would be based on audiological and psychoacoustic research.
Ask a specific question about this device
Page 1 of 1