(31 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description is a standard hearing aid.
Yes
The device is intended to compensate for hearing loss by amplifying sound, which is a therapeutic purpose.
No
Explanation: The device is described as a hearing aid designed to amplify sound to compensate for hearing loss, which is a therapeutic function rather than a diagnostic one.
No
The device description explicitly states "Air Conduction Behind-the-Ear hearing aids," which are hardware devices.
No, 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 provides a physical output (amplified sound) to the user.
- Device Description: The device is described as "Air Conduction Behind-the-Ear hearing aids." This is a type of medical device that aids hearing, not a diagnostic test performed on biological samples.
- Lack of IVD Characteristics: The description lacks any mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition based on the analysis of biological samples.
- Reagents, calibrators, or controls typically associated with IVD tests.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This hearing aid does not fit that description.
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-312 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
Other circuit options may be added as a result of consumer demand. These circuit options would not affect the safety or effectiveness of the A-312 Series.
§ 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
K-966444
MAR - 1 1996
ﺳﺴﺴﺴﺴ SAFETY AND EFFECTIVENESS SUMMARY - Euroline A•312 Series
| NAME OF DEVICES: | A-312 K-Amp, A-312 ISP, A-312 OSP, A-312 Linear.
K-Amp, ISP, OSP, and Linear are the current circuit options available.
Other circuit options may be added as a result of consumer
demand. These circuit options would not affect the safety or
effectiveness of the A-312 Series. |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| TYPE OF DEVICE: | Air Conduction Behind-the-Ear hearing aids - Substantially
equivalent to the Starkey Euroline A Series BTE Hearing Aids
(K940978) |
| 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
on all models. |
| 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 may be
incorporated as options require. Any pots or switches are similar to
those used in other BTE hearing aid devices. |
| POWER: | Standard 312 or equivalent hearing aid battery. |
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( ; ...
1
A160494 (continued)
SUMMARY -- Starkey Euroline A•312 Series SUBSTANTIAL EQUIVALENCE
The Starkey Euroline A-312 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-312 Series BTE Hearing aids are substantially equivalent to the Starkey Laboratories Euroline A Series BTE Hearing aids.
Euroline A-312 Series
- . BTE Air conduction
- Adiustable Gain Control .
- Telephone/Mic/Off Switch .
- Adjustable potentiometers for low fregency, . peak clipping, threshold kneepoint
- 312 or equiv Battery .
- . Miniature size
- Colors: Grey housing and Brown panel or . Brown housing and Brown panel
Euroline A Series
- BTE Air conduction .
- Adjustable Gain Control .
- Telephone/Mic/Off Switch .
- . Adjustable potentiometers for low frequency, peak clipping or AGC, and high frequency attenuation
- . 13 or equiv Battery
- Miniature size .
- Colors: Choice of 15 different skin tone . shades for the side panels of the case.
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