(45 days)
To generate a pleasant white noise stimulus to aid in masking the user's tinnitus (or ringing in the ears)
The Starkey TM air conduction high frequency tinnitus maskers are designed to be behind-the-ear maskers. This form of masker is intended to be received by a Hearing Health Professional in a completed form, not being intended for final assembly. The Starkey TMs are BTE Tinnitus Maskers with a white noise generating circuit which can be tuned to match the frequency and intensity of ringing in the patient's ears (head). The patient has a volume control for this circuit. Variable high and low frequency cut potentiometers can be set by a Dispenser to tune to more specific frequencies.
Here's an analysis of the provided text regarding the Starkey TM series tinnitus maskers, focusing on acceptance criteria and supporting studies.
Based on the provided document, the device's acceptance criteria are centered on substantial equivalence to a previously cleared device, the masking portion of the Starkey CE-8 TML/TMC (K940667). There isn't a performance study in the traditional sense with metrics like sensitivity, specificity, or accuracy for a diagnostic device. Instead, the "study" is a comparison of technical characteristics to establish equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit from Substantial Equivalence) | Reported Device Performance (Starkey TM Series) |
|---|---|---|
| Intended Use | To generate a pleasant white noise stimulus to aid in masking the user's tinnitus (or ringing in the ears). (Same as predicate) | To generate a pleasant white noise stimulus to aid in masking the user's tinnitus (or ringing in the ears). |
| Masking Functionality | Generate white noise, adjustable frequency and intensity (volume). (Same as predicate) | White noise generating circuit, tunable to match frequency and intensity, adjustable masker level control, variable low and high frequency cut potentiometers. |
| General Device Type | Tinnitus masker (Same as predicate) | BTE Tinnitus Maskers |
| Components | Made with standard hearing aid parts. (Same as predicate) | Made with standard hearing aid parts. |
| Power Source | Uses standard hearing aid battery (Predicate: 13, Device: 675). | Uses standard hearing aid 675 battery. |
| Technical Characteristics | Comply with ANSI S3.22-1987 (for the masking portion) | Technical specifications comply with ANSI S3.22-1987. |
| Fit (Frequency Response) | Masker frequency response based on patient needs. Tolerances maintained to a ±4 dB range for SSPL. (Implied for masking function) | Masker frequency response varying based on the needs of the patient. Tolerances are maintained to a ±4 dB range for SSPL. |
| Controls | Adjustable volume control; adjustable masker frequency/level (Predicate: adjustable volume, adjustable masker frequency/level). | Adjustable masker level control, variable low and high frequency cut potentiometers (for frequency adjustment). Volume controls similar to other hearing aids. |
| Assembly | Assembled from standard components commonly used in hearing aid devices. (Implied from predicate) | Assembled from standard components that are widely used in hearing aid devices throughout the industry. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of this submission. There is no "test set" of patient data or device performance data on a cohort of users. The submission focuses on comparing device specifications.
- Data Provenance: Not applicable. The data provided is a comparison of product features and technical specifications, not clinical trial data derived from patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. Ground truth, in this case, is the established technical specifications and intended use of the predicate device and the new device. This isn't a subjective assessment requiring expert consensus on individual cases.
- Qualifications: Not applicable.
4. Adjudication Method (for the test set)
- Adjudication Method: Not applicable. There is no "test set" requiring adjudication. The comparison is based on documented device specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The document does not describe any human reader studies or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Standalone Study: No, this device is a physical medical device, not a software algorithm. Therefore, a standalone algorithm performance study is not applicable.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for this submission is the established technical specifications, functional descriptions, and intended use of thepredicate device (Starkey CE-8 TML/TMC, K940667) and the new device (Starkey TM Series). The comparison is fundamentally against these documented characteristics to demonstrate substantial equivalence.
8. The Sample Size for the Training Set
- Sample Size: Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable. As there is no training set mentioned, the method for establishing its ground truth is irrelevant in this context.
§ 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.