(63 days)
To generate and transmit a pleasant white noise stimulus to aid in masking the user's tinnitus (or ringing in the ears)
Custom fit air conduction Tinnitus Masker
Here's an analysis of the provided text regarding the Starkey TM air conduction tinnitus masker, focusing on the requested acceptance criteria and study information:
Based on the provided text, the "acceptance criteria" appear to be technical specifications and safety standards rather than performance metrics related to the device's efficacy in masking tinnitus. Similarly, there is no detailed "study" described that proves the device meets specific acceptance criteria in terms of its intended use (masking tinnitus).
Here's a breakdown of the requested information based only on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Technical/Safety) | Reported Device Performance (as described) |
|---|---|
| Technical specifications | Comply with ANSI S3.22-1987 |
| Frequency response tolerances | Maintained to a ± 4 dB range for SSPL |
| Components | Assembled from standard components widely used in hearing aid devices |
| Controls | Similar to those used on other hearing aid devices (potentiometers or switches similar to those used in other hearing aid devices) |
| Power Source | Standard hearing aid battery (size 13 for ITE, size 312 for ITC) |
| Substantial Equivalence | Substantially equivalent to the Starkey CE-8 TML/TMC, K940667 |
Note: The document describes the device's characteristics and its compliance with technical standards, but it does not provide performance data related to its intended use of masking tinnitus. For example, there are no metrics like "percentage of users experiencing reduced tinnitus" or "average reduction in perceived tinnitus loudness."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. The provided text does not describe a clinical study or a test set used to evaluate the device's effectiveness in its intended use. The "acceptance criteria" relate to technical specifications and safety, not clinical performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. There is no mention of a test set or ground truth establishment based on expert consensus for the device's performance in masking tinnitus. The compliance with ANSI S3.22-1987 implies adherence to established engineering standards, but not a separate expert evaluation of tinnitus masking efficacy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. As no test set for clinical performance is described, there is no adjudication method mentioned.
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
- No. This device is a tinnitus masker, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical device, not an algorithm. Therefore, a standalone algorithm performance study is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable for clinical efficacy. The "ground truth" implicitly referred to in the context of "Technical specifications comply with ANSI S3.22-1987" is the set of established engineering standards for hearing aids/maskers. This isn't a "ground truth" for clinical outcomes.
8. The sample size for the training set
- Not applicable. There is no mention of a training set as this is a physical device, not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, this question is not relevant.
Summary of Findings from the Provided Text:
The document describes the technical specifications and features of the Starkey TM air conduction tinnitus masker and asserts its compliance with ANSI S3.22-1987 and its substantial equivalence to an earlier model (K940667). It details aspects like controls, power, assembly, and fit. However, the document does not contain any information about a clinical study or performance data demonstrating the device's effectiveness in masking tinnitus in a patient population. The "acceptance criteria" mentioned are technical and regulatory in nature, not performance-based efficacy metrics.
§ 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.