(174 days)
audifon Tinnitus-Module is a tool intended to generate sound as part of a Tinnitus Retraining Therapy (TRT) protocol designed to provide temporary relief for people experiencing tinnitus symptoms. The module in a hearing aid.
audifon Tinnitus-Module is intended for adults over 18 years of age.
audifon Tinnitus-Module is targeted for licensed hearing care professionals who are familiar with the evaluation and treatment of tinnitus and hearing losses. The fitting of audifon Timitus-Module must be done by a hearing care professional participating in a tinnitus management program.
The above mentioned audifon Tinnitus module is a digital noise generator which was developed to be used in a tinnitus retraining therapy. This product has up to four different programs, which can be programmed in shape and level to fit the individual user's needs. The programming can be done with a standard HI-PRO and the audifon audifit software. Within the software the amplification of the device can be fitted to the individual needs. The noise can be adjusted in shape with low- and high-cut filters and in the output level. It can be housed in a standard In-the-ear instrument housing, in a standard behind-the-ear instrument housing as well as in standard receiver-in-the ear housing.
The audifon Tinnitus-Module is a digital noise generator intended to provide temporary relief for tinnitus symptoms as part of a Tinnitus Retraining Therapy (TRT) protocol. The device is designed to be embedded in a hearing aid and is targeted for adults over 18 years of age, with fitting to be done by licensed hearing care professionals.
The study presented to establish substantial equivalence for the audifon Tinnitus-Module primarily relies on non-clinical performance data and a comparison to a legally marketed predicate device, the audifon vico TRT devices (K130514).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by demonstrating equivalence to the predicate device's performance based on official standards (ANSI S3.22-2014) and functional comparisons.
| Criterion | Acceptance Criteria (Predicate Device K130514) | Reported Device Performance (audifon Tinnitus-Module) |
|---|---|---|
| Indications for Use | The combined devices are intended for persons suffering from a chronic persistent ringing in the ears (Tinnitus) in combination with a mild to moderate hearing loss that is indicated for a hearing aid fitting. The products may be used for masking Tinnitus as part of a Tinnitus Retraining Therapy (TRT) protocol and should be utilized only in consultation with a qualified hearing healthcare professional. The devices provide hearing aid amplification to compensate for the hearing loss as well as broadband noise for immediate distraction or masking of Tinnitus or long term habituation of Tinnitus. | A tool intended to generate sound as part of a Tinnitus Retraining Therapy (TRT) protocol designed to provide temporary relief for people experiencing tinnitus symptoms. The module can be embedded in a hearing aid. Intended for adults over 18 years of age. Targeted for licensed hearing care professionals familiar with evaluation and treatment of tinnitus and hearing losses. Fitting must be done by a hearing care professional participating in a tinnitus management program. |
| Operation / Mechanism | Uses broadband noise; Manages tinnitus through masking and distraction. Digital circuit, programmable (Yes), four available noises, volume control, adjustable white-noise, programmable noise level, adjustable Low Battery Indicator, programmable Program Switch Tones. | Uses broadband noise; Manages tinnitus through masking and distraction. Digital circuit, programmable (Yes), four available noises, volume control, adjustable white-noise, programmable noise level, adjustable Low Battery Indicator, programmable Program Switch Tones. |
| Where Used | May be used anywhere. | May be used anywhere. |
| Physical Description | Standard In-the-ear instrument housing, Standard behind-the-ear instrument housing. | Standard In-the-ear instrument housing, Standard behind-the-ear instrument housing, Standard receiver-in-the-ear instrument housing. (Note: The new device offers an additional housing type, which is considered an expansion rather than a deviation from safety/effectiveness). |
| Maximum Output Characteristics | White noise: 107 - 116 dB SPL; frequency range: 100 - 8000 Hz. | White noise: 100 - 112 dB SPL; frequency range: 100 - 8000 Hz. (Note: The rationale states that for TRT, sound levels below 80 dB SPL are typically used and the output level should not exceed 85 dB A per OSHA. A warning in the software occurs for higher levels. Therefore, the slightly lower maximum output has "no influence on the effectiveness of the devices"). |
| Power Source | Standard 10, 312, 13 zinc air 1.4V hearing aid battery. | Standard 10, 312, 13 zinc air 1.4V hearing aid battery. |
| Quality Assurance Standard | ANSI S3.22-2014 to ensure proper functioning of HA. | ANSI S3.22-2014 to ensure proper functioning of HA. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific sample size for a test set for clinical performance evaluations. The supporting data is described as "non-clinical performance data" measured according to official standards (ANSI S3.22-2014). This implies laboratory testing rather than human subject testing.
The data provenance is Germany, where audifon GmbH & Co. KG, the manufacturer, is located. The study is retrospective in the sense that it relies on existing standards and predicate device data, rather than a new prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable, as the evaluation is based on non-clinical performance data and comparison to a predicate device, not on ground truth established by experts for a test set of clinical cases.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document describes a comparison between devices, but not a multi-reader multi-case (MRMC) study involving human readers with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
Yes, in the sense that the "non-clinical performance data" assessed the device's technical specifications (like sound output and frequency range) in isolation, demonstrating its inherent functional capabilities according to industry standards (ANSI S3.22-2014). This is considered a standalone technical performance assessment.
7. The Type of Ground Truth Used
The "ground truth" used is defined by adherence to established industry standards (ANSI S3.22-2014) for hearing aid performance and the functional characteristics of the legally marketed predicate device (audifon vico TRT devices, K130514). This is a technical and regulatory ground truth.
8. The Sample Size for the Training Set
Not applicable. The device is a digital noise generator, not an AI/ML algorithm that requires a training set in the conventional sense. Its functionality is based on programmed parameters and physical acoustic properties.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML algorithm. The device's "ground truth" (i.e., its intended and verified performance) is established through its design specifications and compliance with non-clinical performance standards.
§ 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.