(53 days)
To assist in compensating for hearing loss by amplifying sound as it comes into the ear and to generate a pleasant white noise stimulus to aid in masking the user's tinnitus (or ringing in the ears)
Starkey MA-3 air conduction combination hearing aid / tinnitus masker. Standard BTE air conduction hearing aid. Assembled from standard components that are widely used in hearing aid devices throughout the industry. Technical specifications comply with ANSI S3.22-1987. Frequency response varying based on the needs of the patient. Tolerances are maintained to a ±4 dB range for SSPL and slope, with +5 dB for gain. Volume controls, similar to those used on other hearing aid devices. Potentiometers or switches may be incorporated as options require. Any pots or switches are similar to those used in other hearing aid devices. Standard 1.4 V type 675 hearing aid battery. The Starkey MA-3 air conduction masker aid is designed to be a behind-the-ear hearing aid. This form of hearing aid is intended to be received by a Hearing Health Professional in a completed form, not being intended for final assembly. The Starkey MA-3 is a Starkey BTE Hearing Aid with an additional 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. The hearing aid and masker circuits operate independently of each other, and can be used simultaneously, or either can be used alone. Variable high and low frequency cut potentiometers can be set by a Dispenser to tune to more specific frequencies.
This document describes a hearing aid (Starkey MA-3) and establishes its substantial equivalence to a previously cleared device (Starkey CE-8 TML/TMC). It does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way modern AI/medical device submissions typically do. The "technical characteristics" section mentions compliance with ANSI S3.22-1987, which is a standard for hearing aid performance, but no study data is provided to demonstrate this compliance.
Therefore, many of the requested fields cannot be answered from the provided text.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from Technical Characteristics) | Reported Device Performance |
|---|---|
| Compliance with ANSI S3.22-1987 | Stated as "comply with" |
| Tolerances for SSPL and slope (±4 dB) | Stated as "maintained to" |
| Tolerances for gain (+5 dB) | Stated as "maintained to" |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Provided. This document does not describe a clinical study with a test set.
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/Provided. There is no test set or ground truth described in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Provided. There is no test set described in this document.
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 is a hardware device (hearing aid with tinnitus masker), not an AI-powered diagnostic tool. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable/Provided. There is no clinical study or ground truth establishment described for performance evaluation. The "technical characteristics" refer to compliance with an engineering standard (ANSI S3.22-1987), which would involve physical measurements rather than clinical ground truth.
8. The sample size for the training set
- Not Applicable/Provided. There is no mention of a training set as this is a hardware device submission, not an AI/machine learning model.
9. How the ground truth for the training set was established
- Not Applicable/Provided. As there is no training set, this question is not relevant.
§ 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.