(285 days)
K151719, REVE134
Not Found
No
The summary describes automated processes for generating customized sounds based on patient data, but it does not mention or imply the use of AI or ML algorithms for learning, prediction, or complex pattern recognition. The "pre-process of securing the patient's customized signal" and "test to find tinnitus frequencies" appear to be rule-based or algorithmic rather than AI/ML driven.
Yes
The device is designed to provide "temporary relief for people experiencing tinnitus symptoms" by generating custom sounds for "sound therapy/masking," indicating a therapeutic purpose.
No
The device description clearly states its function is to "create customized sounds with specific frequency range for sound therapy/masking" for tinnitus relief. While it performs a "test to find tinnitus frequencies" automatically, this is a pre-process to generating the masking signal, not a standalone diagnostic function leading to a medical diagnosis. Its intended use is to provide temporary relief, not to diagnose tinnitus or any underlying condition.
Yes
The device description explicitly states "GOLDENEAR COMPANY's TINNITOGRAM™ SIGNAL GENERATOR is a software as a medical device" and "Device type is Stand-alone software as a medical device." It is recommended for use on a PC, but the device itself is the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Tinnitogram™ Signal Generator is a software that generates sounds for tinnitus management. It interacts with the patient through sound, not by analyzing biological specimens.
- Intended Use: The intended use is to provide temporary relief for tinnitus symptoms through sound therapy/masking. This is a therapeutic intervention, not a diagnostic test performed on a sample.
- Device Description: The description focuses on sound generation and customization, not on analyzing biological data.
Therefore, the Tinnitogram™ Signal Generator falls outside the scope of In Vitro Diagnostic devices. It is a software medical device used for therapeutic purposes.
N/A
Intended Use / Indications 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 Timitogram™ Signal Generator signal for 30 minutes twice a day at the barely audible level (minimally detectable level).
Product codes
KLW
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. 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:12912 Hz.
· 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 233
· 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
primarily for adults over 18 years of ages, but may also be used for children 5 years of age or older.
Intended User / Care Setting
hearing healthcare professionals who are familiar with the evaluation and treatment of tinnitus and hearing losses.
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)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K151719 REVE134
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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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
1
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)
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).
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 91354
Phone: (661) 207-1307 |
|----------------------------|----------------------------------------------------------------------------------------------|
| Contact Person: | Daehee Lee
E-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:
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.
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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 to |
| medical 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 | |
| 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). | REVE134 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. REVE134 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 | |||
| REVE134 signal for 30 | |||
| minutes twice a day at the | |||
| barely audible level | |||
| (minimally detectable level). | Same | ||
| User | |||
| Population | Primarily adult population (>18yrs), | ||
| can be used for patients >5yrs | Primarily adult population | ||
| (>18yrs), can be used for | |||
| patients >5yrs | Same | ||
| Schedule of Use | All day | All day | Same |
| Mechanism | Volume is set by HCP and can be | ||
| adjusted by patients, when in use. | |||
| Default level fixed. | |||
| Amplitude modulation noise and | |||
| frequency modulation pure tone. | Volume is set by HCP and | ||
| can be adjusted by patients, | |||
| when in use. Default level | |||
| fixed. | |||
| Amplitude modulation noise | |||
| and frequency modulation | |||
| pure tone. | Same | ||
| Type of Use | Prescription Use | Prescription Use | Same |
| Recommended | |||
| Device to Use | a software as a medical device | ||
| recommended to use a PC (desktop | |||
| or laptop computer) | software installed in PC | ||
| (desktop or laptop | |||
| computer) | Same | ||
| Device Type | Stand-alone software | Software module embedded | |
| into a digital hearing | |||
| instrument platform | Different | ||
| How to | |||
| Perform Test | The test to find tinnitus frequencies | ||
| is performed automatically and this | |||
| masking signal is generated at | |||
| patient's barely audible level. | A hearing healthcare | ||
| professional needs to adjust | |||
| default value into patient's | |||
| barely audible level. | Different | ||
| Test Sound | |||
| Specifications | · Maximum output is 1 kHz, 104 dB | ||
| SPL (based on ISO 226:2003). | |||
| · Initial output is 54 dBr. | |||
| · Measurement frequency range is | |||
| 262~11840 Hz (audible frequency | |||
| range) and it consists of 67 bands. | |||
| · Pulse repetition count of pulsatile | |||
| pure tone is 10 times/sec. | |||
| · Beep type is Pulse Tone with 10 | |||
| times/sec, 50 ms rise-fall time. | · Maximum output is 1 kHz, | ||
| 84 dB SPL. | |||
| · Initial output is 54 dBr. | |||
| · Measurement frequency | |||
| range is 233~12912 Hz. | |||
| · Tone type is modulated | |||
| narrow band tones. | Different | ||
| Generated | |||
| Sound | Customized sounds with specific | ||
| frequency range for sound therapy / | |||
| masking | Customized sounds with | ||
| specific frequency range for | |||
| sound therapy / masking | Same | ||
| Generated | |||
| Sound | |||
| Specifications | · The bandwidth of modulated white | ||
| noise is 233~12912 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. | REVE134 software can | ||
| generate either modulated | |||
| white noise (233~12912 Hz) | |||
| or modulated narrow band | |||
| noises or tones with specific | |||
| frequency range. One | |||
| narrow band noise has a | |||
| frequency range of | |||
| approximately 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.