(24 days)
No
The document does not mention AI, ML, or any related terms, and the description focuses on basic sound amplification.
Yes
The device is described as a hearing aid intended to compensate for hearing loss by amplifying sound, which is a therapeutic function.
No
This device is described as a hearing aid, which amplifies sound to compensate for hearing loss. It does not state that it identifies a disease or condition.
No
The device description explicitly states it is a "behind-the-ear air conduction hearing aid," which is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "To assist in compensating for hearing loss by amplifying sound as it comes near the ear." This describes a device that interacts with the external environment (sound) and the patient's body (hearing loss) directly, not a device that analyzes samples taken from the body (like blood, urine, or tissue) to diagnose or monitor a condition.
- Device Description: The description confirms it's a "behind-the-ear air conduction hearing aid." This is a type of medical device that provides amplification, not a diagnostic test.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information based on sample analysis.
- Using reagents or other materials for in vitro testing.
Therefore, the Starkey Euroline A•675 Series BTE Hearing aids are a hearing aid, which is a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
To assist in compensating for hearing loss by amplifying sound as it comes near the ear.
Product codes
Not Found
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hearing Health Professional
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 -Substantially |
| equivalent to the Starkey A-312 Series BTE Hearing Aids | |
| (K960494) | |
| INTENDED USE: | To assist in compensating for hearing loss by |
| amplifying sound as it comes near the ear . | |
| FEATURES: | Adjustable volume control, Microphone/Telephone/Off |
| switch, direct audio input. | |
| ASSEMBLY: | Assembled from standard components that are widely |
| used in hearing aid devices. | |
| TECHNICAL | |
| CHARACTERISTICS: | Technical specifications comply with ANSI S3.22-1987 |
| and IEC 118-0 1983. | |
| FIT: | For conductive and/or sensori-neural hearing loss where |
| BTE type hearing aids are preferred or required. | |
| CONTROLS: | Volume control, Mic/Telephone/Off switch similar to |
| those used on other hearing aid devices. Potentiometers | |
| and are incorporated as circuit options require. Any pots | |
| or switches are similar to those used in other BTE hearing | |
| aid 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 .
ﺮ ﺩ -
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