(45 days)
No
The description focuses on adjustable white noise generation and does not mention any AI/ML components or functionalities.
Yes
The device is intended to aid in masking tinnitus, which is a medical condition. This indicates a therapeutic intent to alleviate a medical symptom.
No.
The device is described as a tinnitus masker that generates white noise to aid in masking the user's tinnitus. Its purpose is to output sound, not to gather information about a patient's health condition or make a diagnosis. The "tuning to match the frequency and intensity of ringing" is for output adjustment, not for diagnostic measurement.
No
The device description explicitly states it is a "behind-the-ear masker" and mentions hardware components like a "white noise generating circuit," "volume control," and "potentiometers." This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The described device generates white noise to mask tinnitus. It does not perform any tests on biological samples.
- Intended Use: The intended use is to provide a stimulus for masking tinnitus, not to diagnose or monitor a medical condition through analysis of bodily samples.
The device is a therapeutic device designed to alleviate a symptom (tinnitus) through sound therapy.
N/A
Intended Use / Indications for Use
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 TM air conduction high frequency tinnitus maskers are designed to be behind-the-ear maskers. This form of masker 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
Ears (head)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
DEC - 6 1996
SUMMARY- STARKEY TM - SERIES SUBSTANTIAL EQUIVALENCE
The Starkey TM air conduction high frequency tinnitus maskers are designed to be behind-the-ear maskers. This form of masker is intended to be received by a Hearing Health Professional in a completed form, not being intended for final assembly.
The Starkey TMs are substantially equivalent to the masking portion of the Starkey CE-8 TML/TMC (K940667). The Starkey TMs are BTE Tinnitus Maskers with a 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. Variable high and low frequency cut potentiometers can be set by a Dispenser to tune to more specific frequencies. All other aspects of these tinnitus maskers are similar to the masking portion of the Starkey CE-8 TML/TMC.
Starkey TM Series
- BTE ●
- 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 .
- Adjustable 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
1
SAFETY AND EFFECTIVENESS SUMMARY - STARKEY BTE TM SERIES
| NAME OF DEVICE: | Starkey TM Series air conduction high frequency tinnitus
maskers. |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| TYPE OF DEVICE: | Standard BTE air conduction maskers -- Substantially
equivalent to the Starkey masking portion of the CE-8
TML/TMC hearing aid, (K940667) |
| INTENDED USE: | To generate a pleasant white noise stimulus to aid in masking
the user's tinnitus (or ringing in the ears) |
| FEATURES: | Adjustable masker volume controls, control for adjusting
the high and low masker frequencies. |
| ASSEMBLY: | Assembled from standard components that are
widely used in hearing aid devices throughout the
industrv. |
| TECHNICAL | |
| CHARACTERISTICS: | Technical specifications comply with ANSI
S3.22-1987 |
| FIT: | Masker frequency response varying based on the needs of
the patient. Tolerances are maintained to a ±4 dB
range for SSPL. |
| CONTROLS: | Volume controls, similar to those used on other
hearing aid devices. Pots or switches are similar to those
used in other hearing aid devices. |
| POWER: | Standard 1.4 V type 675 hearing aid battery. |
10/15/96
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