The Tinnitus Rx consists of a personalized sound recorded onto a compact disc (CD) that can be played on commercially available players and listened to through commercially available headphones. The recorded sound is equivalent to that generated by a qualified hearing healthcare professional who has followed the treatment regimen utilized in the clinical study (provided in the 210(k)). The device is indicated for adult (18 years and over) tinnitus sufferers who may or may not suffer higher frequencies hearing loss and are participating in a tinnitus management program.

The Tianitus Rx is for home use under the direction of an appropriately qualified healthcare professional.

Patients should receive a medical evaluation by a licensed physician (preferably a physician who specializes in diseases of the ear) to rule out medically or surgically treatable diseases for which timitus is a symptom before proceeding with non-medical tinnitus management.

The Tinnitus Rx is intendod for the temporary relief of timnitus symptoms.

Device Description

The Tinnitus Rx consists of a personalized sound recorded onto a compact disc (CD) that can be played on any commercially available player and listened to through commercially available headphones or speakers.

AI/ML Overview

This document outlines the acceptance criteria and supporting study for the Tinnitus Rx device, a personalized sound recording on a compact disc designed for temporary tinnitus relief.

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of quantitative acceptance criteria for the Tinnitus Rx device. Instead, the basis for substantial equivalence is primarily established by comparing its characteristics and intended use to legally marketed predicate devices (TTCGHI-T, TTCTM-3, and TinniTech ANMP) and by demonstrating its ability to relieve tinnitus through a clinical study.

The core performance claim is the temporary relief of tinnitus symptoms. The device achieves this by providing a personalized sound matching the pitch of the patient's tinnitus, derived through a "scientifically studied clinical protocol."

The comparison table provided in the submission highlights the following aspects related to performance and safety, which can be interpreted as implicit acceptance criteria:

Characteristic	Acceptance Criterion (Implicit)	Reported Device Performance
Intended Use	Provide temporary relief of tinnitus symptoms.	The device is indicated for adult tinnitus sufferers. The clinical study demonstrated relief of tinnitus.
Target Population	Adults (18+) with or without high-frequency hearing loss, participating in a tinnitus management program.	Same as the predicate device, indicating suitability for this population.
Audio Signal Technology	Digital signal processing to generate personalized sound.	Uses digital technology to generate a personalized sound matching the patient's tinnitus pitch.
Safety - Volume Control	Patient labeling warns against playing at excessively loud levels.	"Patient labeling warns patient against playing the CD at a level louder than his/her tinnitus."
Safety - Environment	To be used in a quiet environment; levels not louder than tinnitus.	"The Tinnitus RX is to be used in a quiet environment. The patient is instructed to use the Tinnitus Rx at levels no louder than his/her own tinnitus."
Performance - Patient Experience	Provide a benchmark of the expected effect.	"The pre-CD evaluations at the physician's office provides the patient with a benchmark of the effect he/she should experience with the at-home CD."

Note on Quantitative Data: The 510(k) summary does not include specific quantitative performance metrics (e.g., percentage of patients experiencing relief, average reduction in tinnitus distress scores, etc.) or pre-defined thresholds for these metrics. The approval is based on "substantial equivalence" and the demonstration of the intended effect through the clinical study.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states that "a clinical study showing that the device relieves tinnitus was included in the submission" (referring to the 210(k) instead of 510k). However, the specific sample size used for this clinical study (test set) is not provided in the given excerpt.

Similarly, the data provenance (e.g., country of origin, retrospective or prospective nature) of the clinical study is not mentioned in the provided text.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document mentions that the recorded sound is "equivalent to that generated by a qualified hearing healthcare professional who has followed the treatment regimen utilized in the clinical study." It also states the device is for "home use under the direction of an appropriately qualified healthcare professional."

However, the number of experts used to establish the ground truth for the test set and their specific qualifications (e.g., audiologist with X years of experience, ENT physician) are not specified in the provided information. The "ground truth" here would likely refer to the patient's personalized tinnitus pitch and the effectiveness of the treatment as assessed by professionals.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the test set. The clinical study is mentioned as having a "scientifically studied clinical protocol," but the details of how outcomes were assessed or adjudicated are not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The study described focuses on demonstrating the device's ability to relieve tinnitus symptoms, likely in comparison to baseline or an internal control within the study protocol, rather than comparing human readers' performance with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The Tinnitus Rx device is a a personalized sound recording, not an AI algorithm in the contemporary sense. Its operation involves a "qualified hearing healthcare professional" determining the personalized sound based on a "clinical protocol." Therefore, a "standalone algorithm only" performance study in the context of AI is not applicable to this device. The device's performance is inherently linked to the human professional's initial assessment and customization.

7. Type of Ground Truth Used

The "ground truth" in this context refers to the patient's subjective experience of tinnitus relief, as assessed by the clinical study protocol and guided by qualified healthcare professionals. It would likely involve patient-reported outcomes following the use of the personalized sound, potentially compared to a baseline or through other clinical assessments. The personalized sound itself is based on expert assessment of the patient's tinnitus pitch.

8. Sample Size for the Training Set

The concept of a "training set" as typically understood for machine learning algorithms does not directly apply to the Tinnitus Rx device. The "personalized sound" is derived from individual patient assessment following a "scientifically studied clinical protocol," not from a machine learning model trained on a large dataset. Therefore, a sample size for a training set is not mentioned and is not relevant in the context of this device.

9. How the Ground Truth for the Training Set Was Established

As noted above, a "training set" in the machine learning sense is not applicable. The "ground truth" for the personalized sound is established on an individual patient basis by a "qualified hearing healthcare professional" who follows a "scientifically studied clinical protocol" to match the pitch of the patient's tinnitus. This process is akin to a professional assessment rather than a data-driven model training.

Summary

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510(K) SUMMARY FOR K031624

Sponsor

Daniel S. J. Choy, M.D. Chairman

Tinnitus Control, Inc. 170 East 77th Street New York, New York 10021

2. Device Name

Trade Name of Device	Tinnitus Rx
Common Name	Tinnitus Masker
Classification name	Tinnitus Masker
Product Code	KLW
Regulation Class	II
Regulation Number	§874.3400

3. Indications for Use

The Tinnitus Rx consists of a personalized sound recorded onto a compact disc (CD) that can be played on commercially available players and listened to through commercially available headphones. The recorded sound is equivalent to that generated by a qualified hearing healthcare professional who has followed the treatment regimen utilized in the clinical study (provided in the The device is indicated for adult (18 years and over) tinnitus sufferers who may or may 210(k)). not suffer higher frequencies hearing loss and are participating in a tinnitus management program,

The Tianitus Rx is for home use under the direction of an appropriately qualified healthcare professional.

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The Tinnitus Rx is intendod for the temporary relief of timnitus symptoms.

Device Description 4.

Basis for Substantial Equivalence র্তা

The Tinnitus Rx is substantially equivalent to the TTCGHI-T and TTCTM-3 tinnitus maskers, devices cleared under K982451 and the TinniTech ANMP device cleared under K030791. All of the devices use sound to temporarily relieve a patient's tinnitus. Since the Tinnitus Rx unlizes a custom sound for each patient as opposed to a generic broadband sound, a clinical study showing that the device relieves tinnitus was included in the submission. A comparison table to the ANMP dovice is provided below.

Characteristic	Tinnitus Rx	TinniTech ANMP System
Intended Use	Provide temporary relief oftinnitus symptoms	Continuously andintermittently mask tinnitus aspart of a tinnitus managementprogram with masking noiseand selected music to promotethe relaxation of the patientduring delivery of theTinnitech ANMP therapy
Target Population	Adults (18 years and over)both with and without highfrequency loss, with tinnituswho are participating in atinnitus management program	Adults (18 years and over)both with and without highfrequency loss, with tinnituswho are participating in atinnitus management program
Operation
Audio signaltechnology	Digital	Digital
Availablenoises/sounds	A personalized soundmatching the pitch of thepatient's tinnitus derived byfollowing a scientificallystudied clinical protocol	Pre-adapted to the patient'shearing characteristics. Awide selection of musicalsounds incorporating TinnitusMasking noise (20Hz - 20kHz) digitally recorded onmini compact discs in MP3format.
Medium	One CD	Two mini CDs
Volume Control	Patient labeling warns patientagainst playing the CD at alevel louder than his/hertinnitus	Warning in manual againstplaying CDs at uncomfortablelevels
Distribution	The sale of the custom-madeTinnitus Rx CD will only bethrough a qualified healthcareprofessional	Sold via direct and indirectchannels involving anappropriately qualifiedhealthcare professional
Components	The components of theTinnitus Rx include:• Customized CD• User Manual forphysician• Patient labeling	The components of thecomplete TinniTech ANMOsystem include:• Sound files on storage(mini CDs)• MP3 mini CD player• User Manual
Equipment used	• A commerciallyavailable CD playerthat is capable ofproducing the soundsgenerated from thecustomized CD (AiwaXP-R232recommended).• Headphones with afrequency range of 30	• Philips eXpanium 40mini-disc player withheadphones.
- 20000 HZ and animpedance > 24 ohms.
Characteristic	New device	Predicate device (K030791)
Where used	Home use under anappropriately qualifiedhealthcare professional	Home use under anappropriately qualifiedhealthcare professional
Safety	The Tinnitus RX is to be usedin a quiet environment.The patient is instructed touse the Tinnitus Rx at levelsno louder than his/her owntinnitus.	The ANMP therapy shouldnever be undertaken when thetinnitus masking sounds mightprevent the patient fromhearing cues or warnings oflikely harm or danger.
Performance	The pre-CD evaluations at thephysician's office providesthe patient with a benchmarkof the effect he/she shouldexperience with the at-homeCD.	The TinniTech ANMP systemenables the user to determinewhether the delivered therapyassists in the management oftheir tinnitus.
Instructions	The Tinnitus Rx comes withboth physician and patientinstruction guides.	The TinniTech ANMPSystem comes with a User'sGuide.

Comparison of Tinnitus Rx and TTCGHI-T / TTCTM3-T

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 4 2003

Tinnitus Control, Inc. c/o Dr. Daniel S.J. Choy 170 East 77th Street New York, NY 10021

Re: K031624

Trade/Device Name: Tinnitus Rx Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus Masker Regulatory Class: Class II Product Code: KLW Dated: May 22, 2003 Received: June 5, 2003

Dear Dr. Choy:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Dr. Choy

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Alegi Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K031624 Tinnitus Rx Device Name:

Indications for Use:

The Tinaltus Rx consists of a personalized sound recorded onto a compact disc (CD) that can be played on commercially available players and listened to through commercially available headphones. The rocorded sound is equivalent to that generated by a qualified houring healthcare professional who has followed the reatment regimen utilized in the clinical study (provided in the The device is indicated for adult (18 years and over) tinnitus sufferers who may or may 210(k)). not suffer higher frequencies hearing loss and are participating in a tinnitus management program.

The Tianitus Rx is for home use under the direction of an appropriately qualified healthcare professional.

Paticats should receive a medical evaluation by a licensed physician (proferably a physician who specializes in discases of the car) to rule out medically or surgically treatable diseases for which tinnitus is a symptom before proceeding with non-medical tinnitus management.

The Tinnitus Rx is intonded for the temporary relief of tinnitus symptoms.

Jannz K. Rose, M.O.

510(k) Number

Regulation Number and Section

§ 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.