(88 days)
Not Found
No
The device description and intended use focus on basic audio amplification and bone conduction, with no mention of AI/ML terms or functionalities.
Yes
The device is intended for the "treatment and control of tinnitus" and is used in conjunction with diagnosis and therapy by a healthcare professional, indicating a therapeutic purpose.
No
Explanation: The device is described as being for "treatment and control of tinnitus" and for producing "masking noise." It is explicitly stated that it is "used in conjunction with diagnosis and therapy by a qualified audiologist," implying that the diagnosis is performed separately.
No
The device description explicitly lists hardware components: a compact disc (CD) or MP3 player, an audio amplifier, and a headband/bone-conducted transducer assembly. This indicates it is a hardware device with potentially some software control, not a software-only medical device.
Based on the provided information, the UltraQuiet™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The UltraQuiet™ device does not interact with or analyze any biological specimens.
- The intended use of the UltraQuiet™ is for the treatment and control of tinnitus. This is a therapeutic purpose, not a diagnostic one.
- The device description details components for sound generation and delivery to the body. This aligns with a therapeutic device, not a diagnostic one that analyzes samples.
The UltraQuiet™ device is a therapeutic device used in the management of tinnitus, not a diagnostic device used to analyze biological samples.
N/A
Intended Use / Indications for Use
The UltraQuiet™ device is intended for use in the treatment and control of tinnitus. It consists of a low-level amplifier that converts pre-recorded sound into bone-conducted masking noise that is applied to the mastoid region of the head through a behind-the-ear transducer. The UltraQuiet™ device produces sound of sufficient intensity and bandwidth to mask tinnitus. This device is used in conjunction with diagnosis and therapy by a qualified audiologist or other hearing healthcare professional familiar with the diagnosis of tinnitus and subsequent rehabilitation therapy. UltraQuiet™ is indicated for the treatment of tinnitus in individuals over 18 years of age that report tinnitus.
Product codes (comma separated list FDA assigned to the subject device)
KLW
Device Description
The UltraQuiet™ consists of (1) a compact disc (CD) with recorded sound or an MP3 player, (2) an audio amplifier with AC adapter power supply, and (3) a headband/bone-conduction transducer assembly.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mastoid region of the head
Indicated Patient Age Range
individuals over 18 years of age
Intended User / Care Setting
qualified audiologist or other hearing healthcare 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): 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.
K003559, K981704, K964216, K982452
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
'JUL 1 3 2002
Attachment 7
510(k) SUMMARY
Sound Technique Systems, LLC: UltraQuiet™
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Sound Technique Systems, LLC 710 Denbigh Boulevard, Suite 2C Newport News, VA 23608
Phone: (757) 833-6794 Facsimile: (757) 833-7406
Contact Person: Martin Lenhardt
Date Prepared: March 27, 2002
Name of Device and Name/Address of Sponsor
UltraQuiet™
Sound Technique Systems, LLC 710 Denbigh Boulevard, Suite 2C Newport News, VA 23608
Common or Usual Name
Tinnitus Masker
Classification Name
Tinnitus Masker Product Code: KLW
1
Predicate Devices
| K003559 | Siemens TCI Tinnitus Control Instrument |
|---|---|
| K981704 | ADM Tronics Aurex-3 tinnitus masker |
| K964216 | Starkey TM-3, TM-5 High Frequency Tinnitus Masker |
| K982451 | TTC's GHI-T & TN3-T-T tinnitus masker |
Intended Use
The UltraQuiet™ device is intended for use in the treatment and control of tinnitus. It consists of a low-level amplifier that converts pre-recorded sound into bone-conducted masking noise that is applied to the mastoid region of the head through a behind-the-ear transducer. The UltraQuiet™ device produces sound of sufficient intensity and bandwidth to mask tinnitus. This device is used in conjunction with diagnosis and therapy by a qualified audiologist or other hearing healthcare professional familiar with the diagnosis of tinnitus and subsequent rehabilitation therapy. UltraQuiet™ is indicated for the treatment of tinnitus in individuals over 18 years of age that report tinnitus.
Technological Characteristics and Substantial Equivalence
The UltraQuiet™ consists of (1) a compact disc (CD) with recorded sound or an MP3 player, (2) an audio amplifier with AC adapter power supply, and (3) a headband/bone-conduction transducer assembly.
The Company's UltraQuiet™ device covered by this submission is substantially equivalent to other legally marketed tinnitus maskers. Specifically, the UltraQuiet™ device is substantially equivalent to Siemens' Tinnitus Control Instrument (TCI) (K003559), ADM Tronics' Aurex-3 Tinnitus Masker (K9817040), Starkey Laboratories' Starkey TM-3, TM-5 High Frequency Tinnitus Masker (K964216), and the Tinnitus Treatment Centers' TTCGHI- and TTCTN3-T-T devices (K982452).
UltraQuiet™ has the same general intended use, similar principles of operation, and similar technological characteristics as the previously cleared predicate devices (K003559, K981704, K964216 and K982452). The UltraQuiet™ device and its predicate devices are all tinnitus maskers. The UltraQuiet™ is functionally equivalent to the Siemens' TCI (K003559) in that it provides broadband masking sound at a similar level of intensity (