(53 days)
None
No
The device description focuses on standard hearing aid components and circuits, with no mention of adaptive learning, pattern recognition, or other characteristics typically associated with AI/ML. The "Mentions AI, DNN, or ML" field is also explicitly marked as "Not Found".
Yes
The device is intended to compensate for hearing loss (a medical condition) and to aid in masking tinnitus (another medical condition), which are therapeutic actions.
No
Explanation: The description states the device is designed to amplify sound to compensate for hearing loss and generate white noise to mask tinnitus. It does not mention any function for diagnosing conditions or diseases.
No
The device description explicitly details hardware components such as a standard BTE air conduction hearing aid, standard components, potentiometers, switches, and a standard 1.4 V type 675 hearing aid battery. It is described as a physical device intended to be received by a Hearing Health Professional in a completed form.
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 and masking tinnitus by amplifying sound and generating white noise. This is a direct interaction with the user's auditory system, not an analysis of biological samples.
- Device Description: The device is described as a hearing aid/tinnitus masker that amplifies sound and generates white noise. It's a physical device worn on the ear.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device 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 into the ear and to generate a pleasant white noise stimulus to aid in masking the user's tinnitus (or ringing in the ears)
Product codes
Not Found
Device Description
The Starkey MA-3 air conduction combination hearing aid /tinnitus masker.
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
§ 874.3400 Tinnitus masker.
(a)
Identification. A tinnitus masker is an electronic device intended to generate noise of sufficient intensity and bandwidth to mask ringing in the ears or internal head noises. Because the device is able to mask internal noises, it is also used as an aid in hearing external noises and speech.(b)
Classification. Class II. The special control for this device is patient labeling regarding:(1) Hearing health care professional diagnosis, fitting of the device, and followup care,
(2) Risks,
(3) Benefits,
(4) Warnings for safe use, and
(5) Specifications.
0
NOV 26 1996
X963995
SAFETY AND EFFECTIVENESS SUMMARY - STARKEY MA-3
| NAME OF DEVICE: | Starkey MA-3 air conduction combination hearing aid /
tinnitus masker. |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| TYPE OF DEVICE: | Standard BTE air conduction hearing aid -- Substantially
equivalent to the Starkey CE-8 TML/TMC hearing aid,
(K940667) |
| INTENDED USE: | To assist in compensating for hearing loss by amplifying
sound as it comes into the ear and to generate a
pleasant white noise stimulus to aid in masking the user's
tinnitus (or ringing in the ears) |
| FEATURES: | Adjustable hearing aid volume control, adjustable
masker volume controls, control for adjusting the
masker frequency. |
| ASSEMBLY: | Assembled from standard components that are
widely used in hearing aid devices throughout the
industry. |
| TECHNICAL CHARACTERISTICS: | Technical specifications comply with ANSI
S3.22-1987 |
| FIT: | Frequency response varying based on the needs of
the patient. Tolerances are maintained to a ±4 dB
range for SSPL and slope, with +5 dB for gain. |
| CONTROLS: | Volume controls, similar to those used on other
hearing aid devices. Potentiometers or switches
may be incorporated as options require. Any pots
or switches are similar to those used in other
hearing aid devices. |
| POWER: | Standard 1.4 V type 675 hearing aid battery. |
10/3/96
1
SUMMARY- STARKEY MA-3 SUBSTANTIAL EQUIVALENCE
The Starkey MA-3 air conduction masker aid is designed to be a behind-the-ear hearing aid. 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 MA-3 is substantially equivalent to the Starkey CE-8 TML/TMC (K940667). The Starkey MA-3 is a Starkey BTE Hearing Aid with an additional white noise generating circuit which can be tuned to match the frequency and intensity of ringing in the patient's ears (head). The patient has a volume control for this circuit. The hearing aid and masker circuits operate independently of each other, and can be used simultaneously, or either can be used alone. Variable high and low frequency cut potentiometers can be set by a Dispenser to tune to more specific frequencies. All other aspects of this hearing aid are similar to the Starkey CE-8 TML/TMC.
Starkey MA-3
- BTE ●
- Adjustable Volume Control ●
- Adjustable Masker Level Control
- . Variable Low Frequency Cut (L)
- . Variable High Frequency Cut (H)
- Dispenser can tailor to meet
- individual needs using (L) and (H). ● Made with standard hearing aid parts
- . Uses standard hearing aid 675 battery
Starkey CE-8 TML/TMC
- Custom ITE ●
- Adiustable Volume Control ●
- Adjustable Masker Frequency ●
- Adjustable Masker Level Control
- Color Coded for Left and Right ●
- Hearing aid response tailored to . individual needs
- Made with standard hearing aid ● parts
- Uses standard hearing aid 13 battery