(36 days)
To assist in compensating for hearing loss by amplifying sound as it comes into the ear.
The Starkey A-13 air conduction hearing aids are designed to be behind-the-ear hearing aids. 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 provided text does not describe a study proving the device meets acceptance criteria. Instead, it is a document (K964214 summary) asserting substantial equivalence of the Starkey A-13 Programmable hearing aids to the BOSH Star 42 hearing aid (K942594).
Therefore, I cannot provide the requested information in the format specified.
However, I can extract what might be considered "acceptance criteria" based on the "TECHNICAL CHARACTERISTICS" and "FIT" sections, and how the device "meets" them by referencing adherence to industry standards and general performance descriptions.
Based on the provided text, here's an attempt to categorize the information, but please note that this is an interpretation as a formal study or explicit acceptance criteria with performance against them is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Derived from text) | Reported Device Performance (Derived from text) |
|---|---|---|
| Technical Specifications | Compliance with ANSI S3.22-1987 (Standard for Hearing Aids) | Technical specifications comply with ANSI S3.22-1987. |
| Fit/Tolerances | Frequency response based on patient needs | Frequency response varying based on the needs of the patient. |
| SSPL (Sound-Pressure Level) and Slope Tolerance: ±4 dB | Tolerances are maintained to a ±4 dB range for SSPL and slope. | |
| Gain Tolerance: ±4 dB | Tolerances are maintained to a ±4 dB range for gain. | |
| Intended Use | To assist in compensating for hearing loss by amplifying sound | To assist in compensating for hearing loss by amplifying sound as it comes into the ear. Fits mild to moderate hearing losses (A-13) and moderate to profound (BOSH Star 42, deemed equivalent). |
| Substantial Equivalence | Similar to BOSH Star 42 (K942594) in design and features | Substantially equivalent to the BOSH Star 42 hearing aid. Shares BTE air conduction, adjustable gain, Telephone/Mic/Off Switch. Differences noted (e.g., specific programmable features, battery size, fitting range for A-13 described as "mild to moderate" versus Star 42 "moderate to profound" indicating a range of applicability). |
The remaining requested information (2-9) cannot be provided because the document is a "Summary - Substantial Equivalence" and not a study report.
- There is no study described that involves a test set, ground truth, experts, adjudication, or a multi-reader multi-case comparison.
- The document primarily focuses on comparing the Starkey A-13 with a predicate device (BOSH Star 42) to establish substantial equivalence, meaning it asserts that the new device is as safe and effective as a legally marketed device, rather than providing new performance data from a specific study.
- The mentions of "compliance with ANSI S3.22-1987" and specific tolerances (±4 dB) are statements of design intent and adherence to standards, not results from a specific clinical or technical performance study described within this document.
§ 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.