(34 days)
To assist in compensating for hearing loss by amplifying sound pressure waves as they enter the ear.
Custom fit air conduction hearing aids available as ITE, ITC, or CIC -- Substantially equivalent to the Starkey CE-9 Resolution programmable hearing aid, (K933989). Adjustable hearing aid volume control, color coding for left and right instruments, 6 programmable options: Low cut, High cut, Gain control, Compression ratio, Threshold knee, and Output limiting for Sequel, or Loudness Boost for K Amp. 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 +6 dB, -4 dB for gain. Volume controls, similar to those used on other hearing aid devices. Switches may be incorporated as options require. Any switches are similar to those used in other hearing aid devices. Standard hearing aid batteries.
This document is a 510(k) summary for a hearing aid, which falls under medical device regulation. The information provided is not about an AI/ML device performing analysis or diagnosis. Therefore, several of the requested categories regarding acceptance criteria for AI algorithms, such as sample sizes for test and training sets, expert ground truth, adjudication methods, and MRMC studies, are not applicable to this submission.
The "acceptance criteria" in this context refer to the technical specifications and performance characteristics of the hearing aid, and its equivalence to a predicate device.
Here's an attempt to populate the table with the available relevant information, and explain why other fields are not applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from "Technical Characteristics") | Reported Device Performance (from "FIT" and "Custom Sequel, K Amp Programmable" sections) |
|---|---|
| Technical specifications comply with ANSI S3.22-1987 | (Implicitly Complies, as substantial equivalence is claimed based on these characteristics.) |
| Frequency response varying based on the needs of the patient. | Full range programmability from 100dB SSPL to 117dB SSPL, 20dB gain to 50dB gain. |
| Tolerances maintained to a ± 4 dB range for SSPL and slope. | (Not explicitly stated in the "Reported Device Performance" section, but implied by adherence to ANSI standards and substantial equivalence claim.) |
| Tolerances maintained to +6 dB, -4 dB for gain. | (Not explicitly stated in the "Reported Device Performance" section, but implied by adherence to ANSI standards and substantial equivalence claim.) |
| 6 Programmable Features | 6 Programmable features (Low cut, High cut, Gain control, Compression ratio, Threshold knee, and Output limiting for Sequel, or Loudness Boost for K Amp). |
| Non Volatile Memory | Non Volatile Memory |
| Full range programmability (Predicate: 105dB SSPL to 125dB SSPL, 30dB gain to 60dB gain) | Full range programmability from 100dB SSPL to 117dB SSPL, 20dB gain to 50dB gain |
| Class D output instrument with compression available (Predicate) | Totally programmable class D compression instrument |
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. This submission is for a traditional medical device (hearing aid), not an AI/ML device. Performance is demonstrated through technical specifications and comparison to a predicate device, not through a 'test set' of data in the AI/ML sense.
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. No ground truth established by experts in the context of an AI/ML algorithm's performance. The "ground truth" for a hearing aid's efficacy is its ability to amplify sound appropriately for a patient's hearing loss, which is assessed clinically and through electroacoustic measurements, not expert consensus on data interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method for an AI/ML test set.
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 is not an AI-assisted diagnostic or interpretative device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical hearing aid; there is no 'algorithm only' performance in the context of AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of "Evidence" (instead of ground truth): The "ground truth" for a hearing aid's function is its adherence to technical specifications (e.g., ANSI standards) and its ability to provide acoustic amplification meeting clinical needs. This is typically evaluated through laboratory electroacoustic measurements and clinical fitting. The primary method of demonstration here is substantial equivalence to a legally marketed predicate device (Starkey CE-9 Resolution K933989), meaning its characteristics and intended use are similar enough to the predicate that it raises no new questions of safety or effectiveness.
8. The sample size for the training set
- Not applicable. No 'training set' in the AI/ML sense.
9. How the ground truth for the training set was established
- Not applicable. No 'training set' and therefore no ground truth establishment for it.
§ 874.3300 Air-conduction hearing aid.
(a)
Identification. An air-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. An air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. The air-conduction hearing aid generic type excludes the group hearing aid or group auditory trainer, master hearing aid, and the tinnitus masker, regulated under §§ 874.3320, 874.3330, and 874.3400, respectively.(b)
Classification. Class I (general controls). This device is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 874.9.