The device is intended to be used for the temporary relief of tinnitus. The unit emits an ultrasonic signal that masks or inhibits the sound of timitus in many afflicted individuals. The tip of the device is placed firmly against the bone behind the ear and held in place until the device goes off (60-90 seconds).

This is a medical device and should only be used with the advice of a physician, audiologist or licensed hearing aid dispenser. Only adults 18 years of age and older should be dispensed an instrument.

Device Description

AI/ML Overview

Here’s an analysis of the provided text regarding the acceptance criteria and supporting study for "The Inhibitor" tinnitus masking device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not outline specific, quantified acceptance criteria in the traditional sense (e.g., a target percentage for reduction in tinnitus loudness, or a specific range for duration of relief). Instead, the primary "acceptance criterion" appears to be demonstrating substantial equivalence to predicate devices, particularly concerning safety and intended use (temporary relief of tinnitus).

Acceptance Criterion (Implied)	Reported Device Performance
Safety: Acoustic output below levels causing thermal damage or other known bio-effects, satisfying IEC 61689.	Meets: University of Illinois Bioacoustics Research Laboratory study (9) on predicate HiSonic-TRD measured acoustic output <100 mW/cm², too low to produce thermal damage or other known damaging bio-effects. Satisfies safety limits of IEC 61689. The Inhibitor deemed substantially equivalent in output.
Effectiveness (Temporary Tinnitus Relief): Device provides temporary relief of tinnitus.	Meets (variably): Clinical trials (2,3,4,5,6,7) by Hearing & Balance Research Center observed: "Some individuals who used the device reported that their tinnitus went completely away, others found that the loudness of their tinnitus was reduced and some reported no effect." "Benefit of treatment varied considerably from one individual to another." "The benefit was temporary and their tinnitus eventually returned to the pre-treatment level."
Substantial Equivalence: To predicate devices regarding intended use and technological characteristics (ultrasonic signal for tinnitus masking/inhibition).	Meets: Explicitly stated that "The Inhibitor" is substantially equivalent to predicate devices (HiSonic TDR, Ultra Quiet, Starkey TM-3/TM-5, Siemens TCI) in intended use, technological characteristics (ultrasonic range 20-60 kHz, acoustic output <100 mW/cm²), and safety profile.
No New Issues of Safety or Effectiveness.	Meets: The document repeatedly states that "The Inhibitor raises no new issues of safety or effectiveness," based on its substantial equivalence to predicate devices which have been demonstrated safe and effective.

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

Sample Size: The clinical trials involved an unspecified number of "participants." However, a specific mention is made that "Hearing was evaluated on 14 ears after 16 (one minute) treatments." This refers to a safety evaluation, not directly an efficacy test set for tinnitus relief. For efficacy, the number of participants is not explicitly stated.
Data Provenance: The studies were conducted by:
- The University of Illinois Bioacoustics Research Laboratory (for acoustic output measurements and safety).
- The Hearing & Balance Research Center in Hurst, Texas (for clinical trials on efficacy).
Retrospective or Prospective: Not explicitly stated, but the description of "clinical trials over a three year period (2004 to 2006)" with "procedures" outlined (informed consent, audiological evaluation, rating tinnitus loudness before/after treatment) strongly suggests these were prospective studies.

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

This section is not applicable in the context of this device and study. The "ground truth" for tinnitus relief was based on patient-reported loudness ratings on a 1-10 scale, not an expert panel. For safety, the ground truth was based on physical measurements of acoustic intensity by a bioacoustics research laboratory, not expert consensus.

4. Adjudication Method for the Test Set

This is not applicable. The primary outcome for efficacy was patient self-reporting. There was no mention of an expert panel adjudicating patient responses.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This is not applicable. This device is a direct-to-patient hardware device (tinnitus masker), not an AI-powered diagnostic or assistive tool for human readers (e.g., radiologists). Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. This device is not an algorithm; it is a physical device used by patients, often under the guidance of a healthcare professional. Its performance is its direct effect on a patient's tinnitus.

7. The Type of Ground Truth Used

For Safety: Instrumentational measurements by the University of Illinois Bioacoustics Research Laboratory, comparing acoustic output to known injury mechanisms and safety standards (IEC 61689).
For Efficacy: Patient-reported outcome measures (PROMs), specifically a 1-10 scale for tinnitus loudness, before and after treatment.

8. The Sample Size for the Training Set

This is not applicable. This device is not an AI/machine learning model, and therefore, it does not have a "training set" in the computational sense. The clinical trials evaluated the device itself.

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

This is not applicable, as there is no training set for this type of device.

Summary

{0}------------------------------------------------

K070648

JUN 2 9 2007

510 (k) Summary

Applicant's/Submitter's Name/Address:	Melmedtronics, Inc.1550 Norwood Dr., Suite 100Hurst, TX 76054
Contact Person:	David W. Holmes, Ph.D.
Telephone/Fax:	817-268-1564 voice817-285-6182 faxemail: holmes@melmedtronics.com
Date of Summary:	March 5, 2007
Device Name:
Trade Name:	The Inhibitor™
Common Name:	Tinnitus Masking Device
Classification Name:	Ultra Sonic Tinnitus Masker
Registration Number:	None Assigned
Regulatory Class:	Class II
Regulation Number:	21 CFR 874.3400
Product Code:	77KLW
Performance Standards:	Substantial Equivalence to the following predicate devices:
Device)	K013253 (Hearing Innovations HiSonic TDR Tinnitus Relief
	K021202 (Sound Technique Systems, LLC: Ultra Quiet)
Starkey Labs)	K964216 (Starkey TM-3, TM-5 High Frequency Tinnitus Masker,
	K003559 (Siemens TCI Tinnitus Control Instrument)

Description of Device

The Inhibitor" is a hand-held device that emits a ultrasonic signal in the range of 20 – 60 kHz (depending on the resonant frequency of the Piezo element used). It is powered by a 3.6 V Lithium ion rechargeable battery. The transducer is a piezoelectric element. The acoustic output is <100 mW/cm2 and is similar to the Predicate Device Hearing Innovations TRD ultrasound tinnitus masker (K01235) and Sound Technique Systems, UltraQuiet (K021202). Both of these devices use ultrasound. It is also substantially

{1}------------------------------------------------

equivalent to the Starkey TM-3 & TM-5 High Frequency Tinnitus Masker (K964216) and the Siemens TCI Tinnitus Control Instrument (K003559), as both mask and inhibit tinnitus.

Intended Use of Device

The device is intended to be used for the temporary relief of tinnitus. Some individuals who used the device reported that their tinnitus went completely away, others found that the loudness of their tinnitus was reduced and some reported no effect. The benefit of treatment varied considerably from one individual to another. The length of time ranged from several minutes, to hours, days and in some cases, lasted as long as weeks. There does not appear to be any common denominator that can be used to predict who will receive benefit or how long the benefit will last. However, in all cases, the benefit was temporary and their tinnitus eventually returned to the pre-treatment level.

This is a medical device and should only be used with the advice of a physician. audiologist or licensed hearing aid dispenser. This device should only be dispensed to adults 18 years and older. It is NOT intended for children.

The following precautions should also be followed:

DISCONTINUE USE (IF CURENTLY USING) OR DO NOT BEGIN TO USE IF:

You have a pacemaker. .
You are pregnant. .
You have any bonded metal teeth retainers. .
You have any metal implants in your head or neck. ●
You are prone to migraines or headaches. ●
You have had any recent surgeries (last six months) and are still recovering. .
. You have any thrombosis.
Your tinnitus becomes louder. ●
You get a headache after using the device. ●
You become nauseous after using the device. ●
. You notice any discomfort at the treatment site.
You have any medical condition that your physician would advise against its use.

Technological Characteristics of Device

The Inhibitor "" is a hand-held device that emits a ultrasonic signal in the range of 20 -60 kHz (depending on the resonant frequency of the Piezo element used). It is powered by 3.6 V lithium ion rechargeable battery. The transducer is a piezoelectric element. The acoustic output is <100 mW/cm2 and is similar to the Predicate Device Hearing Innovations TRD ultrasound tinnitus masker (K01235) and Sound Technique Systems, UltraQuiet (K021202). Both of these devices use ultrasound. It is also substantially equivalent to the Starkey TM-3 & TM-5 High Frequency Tinnitus Masker (K964216) and the Siemens TCI Tinnitus Control Instrument (K003559), as both mask and inhibit tinnitus. Numerous studies have demonstrated the hearing Innovations device to be both safe and effective. Thus, The Inhibitor raises no new issues of safety or effectiveness.

{2}------------------------------------------------

Clinical Studies

The University of Illinois Bioacoustics Research Laboratory (9) measured the ultrasound energy emitted by the HiSonic-TRD at maximum output power levels against known injury mechanisms. The output intensity data were calculated against a standard thermal model supported by theoretical and experimental studies on blood and intact tissues. The ultrasound energy has been shown to be too low to produce thermal damage and too low to produce any other known damaging bio-effects. The output satisfies the safety limits of IEC 61689. In a separate study, the University of Illinois Bioacoustics Research Laboratory, performed calibration measurements on the company's HiSonic TRD device. The results of the calibration measurements demonstrated that the device was calibrated and that due to the low level of acoustic intensity (mW/cm)*, output power, generated by the HiSonic-TRD device that it is not possible to reach unsafe acoustic intensity output levels with the device, even at the highest possible setting on the volume wheel.

*The measured output of acoustic devices usually intended for use in the Audiology market is typically specified in dB SPL (decibels, sound pressure level) for air-borne devices and bone conducted auditory devices. If the available national measurement standards were applied to the HiSonic-TRD device, the output data would be misleading. The company provides exposure data in terms of fundamental physical principles. The output of the device is quantified in terms of the temporal-average acoustic power. The unit of measure is the watt. The acoustic power is then normalized to the area of the transducer element; the area is 1.27cm2. The ratio of acoustic power to area is defined as acoustic intensity. Watts/cm-Acoustic intensity. Due to the low level of output power generated by the HiSonic-TRD the acoustic intensity is reported in mWatts per cm- (mW/cm-).

New Device (The Inhibitor)

The new device (The Inhibitor) is substantially equivalent to the predicate device. It has an equivalent surface area, depending on the transducer used (1.27cm - 2.82cm'). Any of the values between these sizes would still result in such low power as to be well below any unsafe acoustic intensity output level.

The Hearing & Balance Research Center in Hurst, Texas conducted several clinical trials over a three year period (2004 to 2006) (2,3,4,5,6,7). They compared several ultrasonic devices that generated different ultrasonic frequencies (broadband noise, sweep frequencies, single frequencies ranging from 19 to 60 kHz) and found similar results among all of the units evaluated.

Procedures

. Each participant signed an Informed Consent.
Each was given a full audiological evaluation. .
. Patient held the device to their mastoid for one minute and then the device was removed.
. Patients rated their tinnitus loudness on a 1 - 10 scale before and after treatment.
Some patients repeated the treatment as many as four times during one session. ●
. Temperature reading were taken at the treatment site (mastoid) before and after treatment.

{3}------------------------------------------------

Hearing was evaluated on 14 ears after 16 (one minute) treatments in a 1.5 to 6.5 hour . time period.

Conclusion

··

The Inhibitor is both safe and effective and is substantially equivalent to the predicate devices cited.

{4}------------------------------------------------

Image /page/4/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Melmedtronics, Inc. c/o David W. Holmes, Ph.D. 1550 Norwood Dr. Suite 100 Hurst, TX 76054

Re: K070648

Trade/Device Name: The Inhibitor Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus Masker Regulatory Class: Class II Product Code: KLW Dated: April 11, 2007 Received: April 13, 2007

JUN 2 9 2007

Dear Dr. Holmes:

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.

{5}------------------------------------------------

Page 2 -- David Holmes

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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

M.B. Eychlesheimer

Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

K070648

Indications for Use

510(k) Number (if known): K070648

Device Name:

DISCONTINUE USE (IF CURENTLY USING) OR DO NOT BEGIN TO USE IF:

1. You have a pacemaker.
1. You are pregnant.
1. You have any metal bonded teeth retainers.
1. You have any metal implants in your head or neck.
1. You are prone to migraines or headaches.
1. You have had any recent surgeries (last six months) and are still recovering.
1. You have any thrombosis.
1. Your tinnitus becomes louder.
1. You get a headache after using the device.
1. You become nauseous after using the device.
1. You notice any discomfort at the treatment site.

You have any medical condition that your physician would advise against its use.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shu Chen Peng

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

510(k) Number

Prescription Use Prescription Use -------------------------------------------------------------------------------------------------------------------------------------------------------------

(Per 21 CFR &

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.