(55 days)
for use in treatment and control of tinnitus.
non-occluding Ultra-helix type shell, two power levels assembled from standard components that are widely used by other hearing aid manufacturers. measured with Fonix™ 6500, 2cc coupler, "Spectrum Mode". typical frequency response as shown on specification filed with 510(k). Response can be tailored to the individual via audiological controls. Volume control, one Audiological Control (tone). Standard hearing aid battery (312)
This document is a 510(k) summary for the Telex Tinnitus-Companion, Models TC TRL and TC TRS. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study proving performance against those criteria. Therefore, much of the requested information is not available in the provided text.
Here's a breakdown of what can and cannot be extracted:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for the device's performance in treating or controlling tinnitus. Instead, it focuses on technical characteristics and comparison to a predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Intended Use: for use in treatment and control of tinnitus. |
| Not specified | Features: non-occluding Ultra-helix type shell, two power levels. |
| Not specified | Assembly: assembled from standard components widely used by other hearing aid manufacturers. |
| Not specified | Technical characteristics: measured with Fonix™ 6500, 2cc coupler, "Spectrum Mode." |
| Not specified | Fit: typical frequency response as shown on specification filed with 510(k). Response can be tailored to the individual via audiological controls. |
| Not specified | Controls: Volume control, one Audiological Control (tone). |
| Not specified | Power: Standard hearing aid battery (312). |
| Not specified | Comparison to predicate device: no significant difference. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a clinical study or a test set of patients/data to evaluate the device's efficacy or performance in treating tinnitus. The "test set" appears to refer only to the technical measurement of the device characteristics.
- Sample size for test set: Not applicable/not mentioned for clinical performance. Technical measurements were likely performed on a sample of the devices themselves, but the size is not specified.
- Data provenance: Not applicable/not mentioned for clinical performance. Technical measurements were conducted by Telex Communications, Inc. in Minneapolis, MN, USA.
- Retrospective or prospective: Not applicable/not mentioned for 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)
This information is not applicable and not provided. The 510(k) summary focuses on demonstrating substantial equivalence based on technical specifications and known intended use for tinnitus maskers, not on a clinical trial with ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there is no mention of a test set involving human judgment or interpretation.
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 a tinnitus masker, an auditory device, and not an AI-powered diagnostic or assistive tool for human readers/interpreters. There is no mention of an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable to a tinnitus masker, which is a physical device intended for use by an individual. It does not contain an algorithm in the sense of AI or automated diagnostic software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The document does not describe a study involving a clinical ground truth for efficacy. The "ground truth" for the submission is the substantial equivalence to the predicate device, K963838 (Starkey TM Air conduction Tinnitus Masker), based on comparable intended use, technology, principles of operation, and safety/effectiveness considerations.
8. The sample size for the training set
Not applicable. This document describes a medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This document describes a medical device, not an AI model.
Summary of available information:
The provided document is a 510(k) premarket notification for a tinnitus masker. Its primary goal is to establish "substantial equivalence" to a predicate device, meaning it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. It does NOT include a clinical study with acceptance criteria, patient populations, or expert ground truth as would be found for new, complex therapeutic or diagnostic devices. The performance reported is largely in terms of technical specifications and a general statement of "no significant difference" compared to the predicate device.
§ 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.