(63 days)
Not Found
No
The summary describes a simple white noise generator for tinnitus masking and explicitly states "Not Found" for mentions of AI, DNN, or ML.
Yes
The device is intended to aid in masking tinnitus, which is a medical condition, thereby providing a therapeutic effect.
No
The device is described as a "Tinnitus Masker" intended to "aid in masking the user's tinnitus." This function is therapeutic (masking/treatment), not diagnostic (identifying or characterizing disease).
No
The device description explicitly states "Custom fit air conduction Tinnitus Masker," which implies a physical hardware component (the masker) that delivers the white noise stimulus. While software might control the stimulus generation and transmission, the device itself is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to generate and transmit white noise to mask tinnitus. This is a physical intervention applied to the user's ears, not a test performed on a biological sample (like blood, urine, or tissue) to diagnose a condition or monitor health.
- Device Description: The device is described as a "Custom fit air conduction Tinnitus Masker." This further reinforces its function as a sound-generating device for therapeutic or symptomatic relief, not a diagnostic tool.
- Lack of IVD Characteristics: The description lacks any mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
To generate and transmit a pleasant white noise stimulus
to aid in masking the user's tinnitus (or ringing in the ears)
Product codes
Not Found
Device Description
Custom fit air conduction Tinnitus Masker -- Substantially equivalent to the Starkey CE-8 TML/TMC, K940667
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ears
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
SAFETY AND EFFECTIVENESS SUMMARY - STARKEY TM
| NAME OF DEVICE: | Starkey TM air conduction tinnitus masker. |
|---|---|
| TYPE OF DEVICE: | Custom fit air conduction Tinnitus Masker -- Substantially |
| equivalent to the Starkey CE-8 TML/TMC, K940667 | |
| INTENDED USE: | To generate and transmit a pleasant white noise stimulus |
| to aid in masking the user's tinnitus (or ringing in the ears) | |
| FEATURES: | Adjustable adjustable masker volume control, control |
| for adjusting the masker frequency, color coding for | |
| left and right instruments. | |
| 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 | |
| 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 hearing aid battery, size 13 for ITE and size 312 for ITC |
9/10/96
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