Tinnitogram™ Signal Generator is a sound generating software used in a Timitus Management Program designed to provide temporary relief for people experiencing timitus symptoms. It is intended primarily for adults over 18 years of ages, but may also be used for children 5 years of age or older.

Tinnitogram™ Signal Generator is for use by hearing healthcare professionals who are familiar with the evaluation and treatment of tinnitus and hearing losses. A hearing healthcare professional should recommend that patient listen to the Timitogram™ Signal Generator signal for 30 minutes twice a day at the barely audible level (minimally detectable level).

Device Description

GOLDENEAR COMPANY's TINNITOGRAM™ SIGNAL GENERATOR is a software as a medical device recommended to use a PC (desktop or laptop computer). TINNITOGRAM™ SIGNAL GENERATOR is fitted to the patient by the healthcare professional. The software enables qualified professional to create customized sounds with specific frequency range for sound therapy/masking.

AI/ML Overview

The provided document is an FDA 510(k) clearance letter and summary for the Tinnitogram Signal Generator, a software device intended to provide temporary relief for tinnitus symptoms.

Based on the content, the device functions as a sound generator for tinnitus management. The primary method of demonstrating acceptance and safety/effectiveness for this device is by showing substantial equivalence to an existing predicate device (KW Ear Lab's REVE134, K151719), rather than through a complex clinical study with specific performance acceptance criteria like those seen for diagnostic or therapeutic devices.

Therefore, the requested information about acceptance criteria and a study proving the device meets those criteria (especially regarding performance metrics like sensitivity, specificity, or improvement in human reader performance) is not applicable in the traditional sense for this submission. The "study" here is essentially the non-clinical performance data (software verification and validation) to establish that the new device functions as intended and safely, despite some differences from the predicate.

Here's an analysis based on the document's content, explaining why some sections of your request cannot be fulfilled and providing information where available:

1. A table of acceptance criteria and the reported device performance

This type of table, with quantitative performance metrics (e.g., sensitivity, specificity, accuracy) and corresponding acceptance thresholds, is typically required for diagnostic or AI-driven decision support devices. For the Tinnitogram Signal Generator, which is a sound-generating software for tinnitus masking, the "acceptance criteria" are related to its functional operation, safety, and equivalence to a predicate device.

Acceptance Criteria (Implied from the submission):
- The software generates sounds for tinnitus masking as intended.
- The software's functions (e.g., automated tinnitus frequency finding, signal generation) operate correctly.
- The software's safety and effectiveness are comparable to the predicate device, despite minor technological differences (e.g., maximum output, how tests are performed).
- The software adheres to relevant medical device software and risk management standards.
Reported Device Performance:
"In all verification and validation process, GOLDENEAR COMPANY's TINNITOGRAM™ SIGNAL GENERATOR functioned properly as intended and the performance observed was as expected."

Note: Specific quantitative performance metrics (e.g., sound output precision, accuracy of frequency determination) are not provided in numerical form in this summary, beyond the specifications listed (e.g., max output 104 dB SPL, frequency range 262-11840 Hz). The "performance" is primarily demonstrated through successful completion of software verification and validation activities.

Table (Best approximation based on available information):

Acceptance Criteria (Implied)	Reported Device Performance
Software generates customized sounds for tinnitus masking.	"Functioned properly as intended."
Software properly performs automated tinnitus frequency finding.	"Functioned properly as intended."
Software's safety is comparable to predicate device.	"Bench performance testing... demonstrated these differences do not affect safety."
Software's effectiveness is comparable to predicate device.	"Bench performance testing... demonstrated these differences do not affect effectiveness."
Adherence to medical device software development standards (IEC 62304).	"Software development, verification, and validation have been carried out in accordance with FDA guidelines."
Adherence to risk management standards (ISO 14971).	"Software Hazard analysis was completed and risk control implemented."
All software specifications meet acceptance criteria.	"The testing results support that all the software specifications have met the acceptance criteria of each module and interaction of processes."

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: This kind of "test set" (e.g., a set of patient data or images) is not applicable here as this is not a diagnostic or AI-based image analysis device. The "test set" in this context refers to the software testing environment.
Data Provenance: Not applicable. The "data" being tested is the software's functionality, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This device uses software verification and validation, not clinical experts establishing ground truth from patient data cases.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not Applicable. As above, this is for software verification, not expert adjudication of clinical cases.

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

No, an MRMC study was not done. This device is a sound generator, not an AI-assisted diagnostic tool that would involve human readers.
Effect Size: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, in spirit, a form of standalone testing was done. The "software as a medical device" was "verified and validated" for its intended functions (e.g., generating signals, performing the automated test to find tinnitus frequencies). This testing assesses the algorithm's performance in isolation from patient interaction, ensuring it produces the correct outputs for given inputs. The summary states: "The software was tested against the established Software Design Specifications for each of the test plans to assure the device performs as intended." This constitutes the "algorithm only" performance assessment.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device is the software's design specifications and expected functional behavior. For instance, if the software is designed to generate a 1 kHz tone at 54 dB SPL, the "ground truth" is that 1 kHz tone at 54 dB SPL, and the testing verifies if the software actually produces it. It's a functional "ground truth" rather than a clinical "ground truth."

8. The sample size for the training set

Not Applicable. This device is not described as using machine learning models that require a training set of data. It is a rule-based or algorithmic sound generator.

9. How the ground truth for the training set was established

Not Applicable. (See #8).

Summary

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February 1, 2023

Goldenear Company, Inc. Daehee Lee CEO 24207 Via Perla Santa Clarita, California 91354

Re: K221168

Trade/Device Name: Tinnitogram Signal Generator Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus Masker Regulatory Class: Class II Product Code: KLW Dated: January 5, 2023 Received: January 5, 2023

Dear Daehee Lee:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 FD A 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shuchen Peng -S

Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221168

Device Name TINNITOGRAM™ SIGNAL GENERATOR

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)	□ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary (TINNITOGRAMTM SIGNAL GENERATOR)

Submitter:	GOLDENEAR COMPANY, INC.24207 Via Perla, Santa Clarita, CA 91354Phone: (661) 207-1307
Contact Person:	Daehee LeeE-mail: day@Goldenearclub.com
Submission Number:	K221168
Date Prepared:	Feb 1, 2023
Device Name:	TINNITOGRAM™ SIGNAL GENERATOR
Software Version:	V1.0
Device Class:	Class II
Classification Name:	Tinnitus Masker
Classification Regulation:	21 C.F.R. 874.3400
Product Code:	KLW
Predicate Device:	K151719 REVE134, KW Ear Lab
Prior Related Submission:	No prior submissions for the subject device

Intended Use / Indication for Use:

Tinnitogram™ Signal Generator is a sound generating software used in a Tinnitus Management Program designed to provide temporary relief for people experiencing tinnitus symptoms. It is intended primarily for adults over 18 years of ages, but may also be used for children 5 years of age or older.

Tinnitogram™ Signal Generator is for use by hearing healthcare professionals who are familiar with the evaluation and treatment of tinnitus and hearing losses. A hearing healthcare professional should recommend that patient listen to the Tinnitogram™ Signal Generator signal for 30 minutes twice a day at the barely audible level (minimally detectable level).

Technological Characteristics:

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Device type is Stand-alone software as a medical device. The tinnitus masking signal is generated through a pre-process of securing the patient's customized signal. The test to find tinnitus frequencies, the pre-process, is performed automatically and this masking signal is generated at patient's barely audible level. The test sound specifications to find tinnitus frequencies of TINNITOGRAM™ SIGNAL GENERATOR are as follows: · Maximum output is 1 kHz, 104 dB SPL (based on ISO 226:2003); · Initial output is 54 dBr; · Measurement frequency range is 26211840 Hz (audible frequency range) and it consists of 67 bands: · Pulse repetition count of pulsatile pure tone is 10 times/sec; and · Beep type is Pulse Tone with 10 times/sec, 50 ms rise-fall time. The sounds that can be generated with the TINNITOGRAM™ SIGNAL GENERATOR software are detailed as follows: · The bandwidth of modulated white noise is 23312912 Hz. · The frequency range of modulated narrow band noises / tones has a frequency range of approximately 1/3 octave, and it depends on patient's hearing threshold. Performance Data: GOLDENEAR COMPANY's TINNITOGRAM™ SIGNAL GENERATOR software as a medical device has been verified and validated according to relevant standards for medical device software and risk management procedure below. In all verification and validation process, GOLDENEAR COMPANY's TINNITOGRAM™ SIGNAL GENERATOR functioned properly as intended and the performance observed was as expected.

Standard No.	Standard Title
IEC62304:2006/Amd 1:2015	Medical device software – Software life-cycle processes
ISO14971:2019	Medical devices - Application of risk management tomedical devices

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Comparison Table: GOLDENEAR COMPANY Inc. TINNITOGRAM™ SIGNAL GENERATOR

Device	Subject	Predicate	Discussion
Manufacturer	GOLDENEAR COMPANY	KW Ear Lab
Name	Tinnitogram™ Signal Generator	REVE134
510(K) No.	K221168	K151719
Indicationfor Use	Tinnitogram™ Signal Generator is asound generating software used in aTinnitus Management Programdesigned to provide temporary relieffor people experiencing tinnitussymptoms. It is intended primarilyfor adults over 18 years of ages, butmay also be used for children 5years of age or older.Tinnitogram™ Signal Generator isfor use by hearing healthcareprofessionals who are familiar withthe evaluation and treatment oftinnitus and hearing losses. Ahearing healthcare professionalshould recommend that patientlisten to the Tinnitogram™ SignalGenerator signal for 30 minutestwice a day at the barely audiblelevel (minimally detectable level).	REVE134 is a soundgenerating software used ina Tinnitus ManagementProgram designed to providetemporary relief for peopleexperiencing tinnitussymptoms. It is intendedprimarily for adults over 18years of ages, but may alsobe used for children 5 yearsof age or older. REVE134 isfor use by hearing healthcareprofessionals who arefamiliar with the evaluationand treatment of tinnitus andhearing losses. A hearinghealthcare professionalshould recommend thatpatient listen to theREVE134 signal for 30minutes twice a day at thebarely audible level(minimally detectable level).	Same
UserPopulation	Primarily adult population (>18yrs),can be used for patients >5yrs	Primarily adult population(>18yrs), can be used forpatients >5yrs	Same
Schedule of Use	All day	All day	Same
Mechanism	Volume is set by HCP and can beadjusted by patients, when in use.Default level fixed.Amplitude modulation noise andfrequency modulation pure tone.	Volume is set by HCP andcan be adjusted by patients,when in use. Default levelfixed.Amplitude modulation noiseand frequency modulationpure tone.	Same
Type of Use	Prescription Use	Prescription Use	Same
RecommendedDevice to Use	a software as a medical devicerecommended to use a PC (desktopor laptop computer)	software installed in PC(desktop or laptopcomputer)	Same
Device Type	Stand-alone software	Software module embeddedinto a digital hearinginstrument platform	Different
How toPerform Test	The test to find tinnitus frequenciesis performed automatically and thismasking signal is generated atpatient's barely audible level.	A hearing healthcareprofessional needs to adjustdefault value into patient'sbarely audible level.	Different
Test SoundSpecifications	· Maximum output is 1 kHz, 104 dBSPL (based on ISO 226:2003).· Initial output is 54 dBr.· Measurement frequency range is262~11840 Hz (audible frequencyrange) and it consists of 67 bands.· Pulse repetition count of pulsatilepure tone is 10 times/sec.· Beep type is Pulse Tone with 10times/sec, 50 ms rise-fall time.	· Maximum output is 1 kHz,84 dB SPL.· Initial output is 54 dBr.· Measurement frequencyrange is 233~12912 Hz.· Tone type is modulatednarrow band tones.	Different
GeneratedSound	Customized sounds with specificfrequency range for sound therapy /masking	Customized sounds withspecific frequency range forsound therapy / masking	Same
GeneratedSoundSpecifications	· The bandwidth of modulated whitenoise is 233~12912 Hz.· The frequency range of modulatednarrow band noises / tones has afrequency range of approximately1/3 octave, and it depends onpatient's hearing threshold.	REVE134 software cangenerate either modulatedwhite noise (233~12912 Hz)or modulated narrow bandnoises or tones with specificfrequency range. Onenarrow band noise has afrequency range ofapproximately 1/3 octave.	Same

Substantial Equivalence Chart

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Substantial Equivalence:

GOLDENEAR COMPANY's TINNITOGRAM™ SIGNAL GENERATOR is as safe and effective as KW Ear Lab's REVE134 (K151719). As shown in the table above, the subject device has the same indications for use, user population, and mechanism as its predicate device. Test sound specifications, device type, and how to perform test are different as those of the predicate device. However, these differences in test sound specifications (e.g., maximum output level) do not raise different questions of safety and effectiveness. Bench performance testing of the subject device has been conducted to demonstrate that these differences do not affect safety and effectiveness of the subject device compared to the predicate device.

Non-Clinical Performance Data:

The device's software development, verification, and validation have been carried out in accordance with FDA guidelines. The software was tested against the established Software Design Specifications for each of the test plans to assure the device performs as intended. The Software Hazard analysis was completed and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria of each module and interaction of processes. The GOLDENEAR COMPANY's TINNITOGRAM™ SIGNAL GENERATOR device passed all testing and supports the claims of substantial equivalence and safe operation.

The referenced FDA guidelines are as follows:

les of Software Validation General Princip ●
Software as a Medical Device (SaMD): Clinical Evaluation
Guidance for the Content of Premarket Submissions for Software Contained ● in Medical Devices

Clinical Performance Data:

There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device.

Conclusion:

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 874.3400 and based on the analysis and empirical validation of the above information and comparison table, the GOLDENEAR COMPANY, Inc. concludes that the TINNITOGRAM™ SIGNAL GENERATOR is as safe and as effective and substantially equivalent to the predicate device.

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.