(31 days)
To assist in compensating for hearing loss by amplifying sound as it comes near the ear .
Air Conduction Behind-the-Ear hearing aids
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Euroline A•312 Series hearing aid.
The provided document describes a hearing aid, a device that amplifies sound to compensate for hearing loss. The regulatory submission focuses on demonstrating substantial equivalence to an existing device, rather than proving performance against specific quantitative acceptance criteria through clinical trials or algorithmic studies typically associated with AI/ML devices.
Therefore, many of the requested fields are not applicable (N/A) because the device is a conventional medical device, not an AI/ML system. The "acceptance criteria" are primarily related to safety and technical specifications, and the "study" is a comparison to a predicate device for substantial equivalence.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Starkey Euroline A-312 Series) | Reported Device Performance (Starkey Euroline A-312 Series) |
|---|---|
| Intended Use: To assist in compensating for hearing loss by amplifying sound as it comes near the ear. | Intended for this use. |
| Device Type: Air Conduction Behind-the-Ear hearing aid. | Described as a BTE (Behind-the-Ear) air conduction hearing aid. |
| Technical Characteristics: Comply with ANSI S3.22-1987 and IEC 118-0 1983. | Stated that technical specifications comply with ANSI S3.22-1987 and IEC 118-0 1983. (Specific performance values against these standards are not provided in this summary but are implied by compliance.) |
| Features: Adjustable volume control, Microphone/Telephone/Off switch on all models. | Has Adjustable Gain Control (volume control) and Telephone/Mic/Off Switch. |
| Adjustable Potentiometers: For low frequency, peak clipping, threshold kneepoint. | Has Adjustable potentiometers for low frequency, peak clipping, threshold kneepoint. (Note: Predicate device also mentions AGC and high frequency attenuation adjustable potentiometers, so the A-312 falls within similar adjustability). |
| Power: Uses Standard 312 or equivalent hearing aid battery. | Uses 312 or equivalent Battery. |
| Size: Miniature size. | Described as Miniature size. |
| Assembly: Assembled from standard components widely used in hearing aid devices. Not intended for final assembly by the user (received by a Hearing Health Professional in completed form). | Stated to be assembled from standard components. Not intended for final assembly, received by a Hearing Health Professional in a completed form. |
| Fit: For conductive and/or sensori-neural hearing loss where BTE type hearing aids are preferred or required. | Intended for this fit and hearing loss types. |
| Controls: Volume control, Mic/Telephone/Off switch similar to those used on other hearing aid devices. Optional potentiometers/switches similar to those in other BTE hearing aids. | Has Volume control and Mic/Telephone/Off switch. Potentiometers are similar to those in other BTE hearing aids. |
| Colors: Grey housing and Brown panel or Brown housing and Brown panel. | Offers these color options, which are comparable to the predicate's choice of 15 different skin tone shades. |
| Substantial Equivalence to Predicate Device: Starkey Laboratories Euroline A Series BTE Hearing aids (K940978). | The entire document serves to demonstrate substantial equivalence to the Starkey Laboratories Euroline A Series BTE Hearing aids. |
Study to Prove Acceptance Criteria:
The "study" presented here is a substantial equivalence comparison to a predicate device (Starkey Laboratories Euroline A Series BTE Hearing aids, K940978). The document highlights the similarities between the new Euroline A-312 Series and the predicate device across various features, technical specifications, and intended use. The core of the argument is that because the new device is fundamentally similar to an already cleared device, it is considered safe and effective without requiring new clinical trials to establish its own independent performance or safety profiles from scratch.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: N/A (No specific test set or clinical data is presented for this substantial equivalence argument, as it's a comparison of device specifications and characteristics, not a performance study of an AI/ML algorithm.)
- Data Provenance: N/A
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)
- Number of Experts: N/A
- Qualifications of Experts: N/A
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: N/A
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
- MRMC Study: No, this is not an AI/ML device, and no MRMC study was conducted.
- Effect Size: N/A
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Study: No, this is not an AI/ML device, and no standalone algorithm performance study was conducted.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: The "ground truth" in this context is the established safety and effectiveness of the predicate device (Starkey Laboratories Euroline A Series BTE Hearing aids, K940978) based on its prior clearance and presumably its adherence to industry standards. The new device's conformity to these standards and functional similarity to the predicate serves as its "ground truth" for regulatory purposes in this submission.
8. The sample size for the training set
- Sample Size for Training Set: N/A (No AI/ML training set is applicable to this device.)
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: N/A
§ 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.