(24 days)
To assist in compensating for hearing loss by amplifying sound as it comes near the ear .
The Starkey Euroline A•675 Series BTE Hearing aids are behind-the-ear air conduction 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Euroline A•675 Series hearing aid:
Based on the provided documents, it is not possible to provide a complete answer to your request. The documents describe the device (Euroline A•675 Series hearing aids) and its substantial equivalence to another device (Starkey A-312 Series BTE Hearing Aids and Euroline A-13 Series BTE hearing aids). However, they contain no information about specific acceptance criteria or any study (clinical or otherwise) that proves the device meets those criteria.
The text focuses on technical specifications and features, indicating compliance with general standards like ANSI S3.22-1987 and IEC 118-0 1983. However, these are general standards and not specific acceptance criteria linked to a performance study.
Therefore, I cannot populate the requested table or answer the specific questions about sample size, expert ground truth, adjudication, MRMC studies, standalone performance, or training set details because this information is not present in the provided text.
Here's what can be extracted from the provided text, but it falls short of your request:
Description of the Device and its Intended Use:
- NAME OF DEVICES: A•675 TSP, A•675 Sequel
- TYPE OF DEVICE: Air Conduction Behind-the-Ear hearing aids
- INTENDED USE: To assist in compensating for hearing loss by amplifying sound as it comes near the ear.
- TECHNICAL CHARACTERISTICS: Technical specifications comply with ANSI S3.22-1987 and IEC 118-0 1983. (This is the closest to a "standard" or "criteria" mentioned, but it's a general compliance statement, not performance-based acceptance criteria from a study).
Summary of missing information directly related to your request:
- Specific Acceptance Criteria: Not defined.
- Reported Device Performance against Acceptance Criteria: Not provided.
- Study Details (test set sample size, data provenance, number of experts, adjudication, MRMC, standalone performance, ground truth type, training set sample size, ground truth establishment for training set): None of this information is available in the provided text.
It appears the provided documents are likely part of a regulatory submission primarily focused on demonstrating substantial equivalence to a predicate device based on features and technical specifications, rather than a detailed report of a performance study with explicit acceptance criteria.
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SEP 2 7
K9635/9
SAFETY AND EFFECTIVENESS SUMMARY - Euroline A•675 Series
| NAME OF DEVICES: | A•675 TSP, A•675 Sequel |
|---|---|
| TYPE OF DEVICE: | Air Conduction Behind-the-Ear hearing aids -Substantiallyequivalent to the Starkey A-312 Series BTE Hearing Aids(K960494) |
| INTENDED USE: | To assist in compensating for hearing loss byamplifying sound as it comes near the ear . |
| FEATURES: | Adjustable volume control, Microphone/Telephone/Offswitch, direct audio input. |
| ASSEMBLY: | Assembled from standard components that are widelyused in hearing aid devices. |
| TECHNICALCHARACTERISTICS: | Technical specifications comply with ANSI S3.22-1987and IEC 118-0 1983. |
| FIT: | For conductive and/or sensori-neural hearing loss whereBTE type hearing aids are preferred or required. |
| CONTROLS: | Volume control, Mic/Telephone/Off switch similar tothose used on other hearing aid devices. Potentiometersand are incorporated as circuit options require. Any potsor switches are similar to those used in other BTE hearingaid devices. |
| POWER: | Standard 675 or equivalent hearing aid battery. |
8/26/96
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SUMMARY -- Starkey Euroline A 675 Series SUBSTANTIAL EQUIVALENCE
The Starkey Euroline A•675 Series BTE Hearing aids are behind-the-ear air conduction 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 Euroline A•675 Series BTE Hearing aids are substantially equivalent to the Starkey Laboratories Euroline A-13 Series BTE Hearing aids.
Euroline A 675 Series
Euroline A-13 Series
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BTE Air conduction .
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Adjustable Gain Control ●
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Telephone/Mic/Off Switch .
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Adjustable potentiometers for low . fregency, peak clipping, gain, high frequency attenuation, high or low freq compression, and crossover frequency
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675 or equiv Battery .
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High output, High gain .
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Colors: Beige or Dark brown .
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BTE Air conduction .
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Adjustable Gain Control .
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Telephone/Mic/Off Switch ●
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Adjustable potentiometers for low . frequency, peak clipping or AGC, and high frequency attenuation
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13 or equiv Battery .
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Miniature size .
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Colors: Choice of 15 different skin ton
6/26/96
§ 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.