(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.
{0}------------------------------------------------
Nov 26 1996
SUMMARY-- STARKEY A-13 PROGRAMMABLES SUBSTANTIAL EQUIVALENCE
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 Starkey A-13s are substantially equivalent to the BOSH Star 42 hearing aid (K942594). Variable high and low frequency cut potentiometers can be set by a Dispenser to tune to more specific frequencies. All other aspects of these A-13s are similar to the BOSH Star 42 hearing aid.
Starkey A-13 Programmable Sequel / K-AMP
- BTE air conduction ●
- Adiustable Gain Control ●
- Six program features ●
- Programmable using the . Professional Fitting System software and Pro-connect or High-Pro Systems.
- Programmable using the PR 3000 . or PFS 6000 with PFS software
- . Fits mild to moderate hearing losses
- Audio input capabilities ●
- Telephone/Mic/Off Switch ●
- 13 or equiv. battery ●
Bosh Star 42 Digitally Programmable
- BTE air conduction .
- Adjustable Gain Control .
- Telephone/Mic/Off Switch .
- Digitally programmable using the . Starkey Trilogy desktop programmer or the Pro-connect system
- 10 programmable features .
- Fits moderate to profound hearing . losses
- Audio input capabilities ●
- 675 or equiv. battery .
- Colors: Exchangeable casings . available in various colors
10/16/96
{1}------------------------------------------------
SAFETY AND EFFECTIVENESS SUMMARY - STARKEY A-13 PROGRAMMABLE HEARING AIDS
| NAME OF DEVICE: | Starkey A-13 Sequel programmable, A-13 K-AMPprogrammable air conduction hearing aids. |
|---|---|
| TYPE OF DEVICE: | Standard BTE air conduction hearing aids -- Substantiallyequivalent to the Bosh Star 42 hearing aid, (K942594) |
| INTENDED USE: | To assist in compensating for hearing loss by amplifyingsound as it comes into the ear. |
| FEATURES: | Adjustable hearing aid volume controls, six programmabletrimmer options, and telephone switch. |
| ASSEMBLY: | Assembled from standard components that arewidely used in hearing aid devices throughout theindustry. |
| TECHNICALCHARACTERISTICS: | Technical specifications comply with ANSIS3.22-1987 |
| FIT: | Frequency response varying based on the needs ofthe patient. Tolerances are maintained to a ±4 dBrange for SSPL. and slope, with ±4dB for gain. Forconductive and/or sensori-neural hearing loss whereBTE type hearing aids are preferred or required. |
| CONTROLS: | Volume controls, similar to those used on otherhearing aid devices. Pots or switches are similar to thoseused in other hearing aid devices. |
10/16/96
§ 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.