(277 days)
The Tinnitus Sound Generator Module is a tool to generate sounds to be used in a Tinnitus Management Program to temporarily relieve patients suffering from Tinnitus. The target population is primarily the adult population over 18 years of age. This product may also be used with children 5 years of age or older. The Tinnitus Sound Generator module is targeted for healthcare professionals, which are treating patients suffering from Tinnitus, as well as conventional hearing disorders. The Tinnitus Sound Generator module must be done by a hearing professional participating in a Tinnitus Management Program.
The Tinnitus Sound Generator (TSG) Module provides a means for healthcare professionals to create a hearing instrument solution that provides temporary relief for Tinnitus patients. This software solution is embedded into a digital hearing instrument platform, so that the end-user (EU) can wear this device in all environments. The fitting of the digital device, which contains the TSG Module, is performed by a healthcare professional, in order to meet the exact needs of the Tinnitus patient. A mobile medical application (app) is available as an optional device to use with the TSG. The mobile medical app allows the user to adjust the hearing aid within the limits set by the healthcare professional during fitting of the hearing aid. The app is known as the TSG Tinnitus Manager app and is part of the Smart3D app. The subject TSG Module has a new feature. i.e., Remote Fine-tuning (RFT) communication software (PC Interface software) that communicates with a healthcare professional's Fitting Software (FSW) via the user's Smart3D app and is part of the general software on the digital signal processor in GN's legally marketed, class II, 510(k) exempt Hearing Aids (Reference Device). The RFT communication software in the Reference device enables the healthcare professional to remotely adjust the Hearing Aid settings for these legally marketed, class II, 510(k) exempt Hearing Aids, including Hearing Aids that are compatible with the predicate TSG Module and the new TSG Module. Similarly, the new TSG Module has a PC Interface Software modification that supports fine tuning of TSG Module settings from a remote location. The new TSG Module's PC Interface Software modification opens a bridge between the general RFT function on the Hearing Aid's digital signal processor and the TSG feature settings, that are also available for adjustments via the user's Smart3D app. Therefore, the RFT communication software part of the general software on the Hearing Aids containing the new TSG Module is also part of new TSG Module device. The Health Care Professional (HCP) can make all of the same changes (Volume/loudness, Pitch/frequency. Nature sounds, and Amplitude modulation) that the user can make. Additionally, the HCP can turn the TSG/tinnitus masker on or off and can set and adjust the Volume Control range and environmental steering sounds. The TSG Volume Control range feature is available only to the HCP. This feature allows the HCP to set a limit on the TSG volume range an EU can adjust. This feature is specifically designed for the safety of the EU, ensuring that an EU cannot increase the TSG volume above a level determined appropriate by the HCP. The system can in no case exceed 100dB SPL for TSG. The TSG Volume Control range has a range of +12dB to -6dB from the TSG fitting by the HCP and can be found in the FSW under the Fitting / Manual Controls / Volume Control Range. For example, if the HCP sets the TSG Volume Control range to +6dB to -6dB, this means an EU cannot set the TSG volume more than 6dB above or below the initial fitting.
The provided text is a 510(k) summary for the Tinnitus Sound Generator Module (K180495). It details the device, its intended use, comparison with a predicate device, and performance data. However, it does not include specific quantitative acceptance criteria or a detailed study proving the device directly meets those criteria with statistical data.
Instead, the document focuses on demonstrating substantial equivalence to an existing predicate device (Tinnitus Sound Generator Module, K181586) and a reference device (LiNX3D hearing aid) by showing that the minor modifications do not raise new questions of safety or effectiveness.
Therefore, the following information is extracted and where specific details are not present, it is noted.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present quantitative acceptance criteria or performance metrics for the Tinnitus Sound Generator Module itself (e.g., how effectively it reduces tinnitus symptoms in a specific percentage of patients). Instead, it relies on demonstrating that its design, performance, and technological characteristics are safe and effective, and do not differ significantly from a legally marketed predicate device.
The performance data described focuses on verification and validation of the system and its RFT feature, rather than direct clinical efficacy trials with acceptance criteria.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Safety and Effectiveness (General) | "The results of risk analysis and design verification and validation activities provide evidence that the new device is as safe and effective as its predicate and therefore, demonstrate that the TSG Module is substantially equivalent to the predicate device." "The system verification outcome, together with the TSG Module verification and validation outcome, supports substantial equivalence of the subject device compared to the Predicate Device, verified and validated under similar conditions at GN Hearing." |
| Electromagnetic Compatibility (EMC) and Safety of Exposure to Non-Ionizing Radiation | "EMC testing was done in accordance to the appropriate standards IEC 60601-1-2 and IEC 60118-13. EMF assessment was done in accordance to IEC 62311 and IEC 62479. The tests and the assessment were performed by the accredited test house: DEKRA Testing and Certification, S.A.U... Test reports demonstrate compliance to the FDA medical device recognized standards, and the regulatory radio requirements in relation to the US Federal Communications Commission (FCC). The testing and the assessment demonstrate that the implemented wireless technology is safe." |
| Wireless Technology Functions (Design, Description, Performance) | "The design controls activities for the LiNX3D hearing aid are identical to the activities described in Annex IX of the K180495 submission. The GN Hearing New Product Development process #0216640 were followed. The wireless technology was developed and documented as part of this process and performance data in the form of verification of all wireless technology requirements." "The features using the wireless technology in relation to RFT were verified and validated to be safe and effective as part of the design process." |
| Labeling for EMC and Wireless Technology | "Risk controls related to wireless technology, identified as part of the Risk Management, include labeling requirements with appropriate instructions, warnings, and information related to EMC and wireless technology and human exposure to non-ionizing radiation. The user guide informs the user about the device containing a RF transmitter operating wireless, and the precautions related to that, like coexistence with other devices, flight mode, etc." |
| Remote Fine-tuning (RFT) Safety and Effectiveness | "The successful validation activities related to the RFT feature were conducted to show that human factors and usability are safe and effective." "The system verification outcome, together with the TSG Module verification and validation outcome, also supports substantial equivalence of the RFT Feature in the subject device compared to the predicate device, showing that RFT is safe and effective." |
| System End-to-End Testing and Interoperability | "The system verification includes system end-to-end testing and interoperability performance testing. The result of the system verification show that test has passed with no defects critical for function, form, intended use, or pose any user risks." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a separate "test set" with a given sample size in the context of clinical data or patient studies. The performance data refers to verification and validation activities of the device's design and software, and electromagnetic compatibility (EMC) testing. These are primarily engineering and technical tests.
- Sample Size: Not applicable in a clinical sense. The hardware and software components of the system (Hearing Instruments, App, Fitting Software) were tested.
- Data Provenance: The EMC testing was performed by DEKRA Testing and Certification, S.A.U. in Spain. The nature of the other verification and validation activities (e.g., system end-to-end testing) suggests they were conducted internally by GN Hearing. The document does not specify if any user data was collected for these tests, nor its country of origin or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the document describes technical verification and validation, and EMC testing, rather than a study requiring expert consensus for a ground truth derived from clinical data. The "ground truth" for these tests would be compliance with engineering standards and design requirements, as determined by qualified engineers and testers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. The verification and validation activities described are technical and engineering-focused, not clinical studies requiring adjudication of results based on expert review.
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. The Tinnitus Sound Generator Module is a therapeutic device that generates sounds for tinnitus relief, not an diagnostic AI tool for human readers. No MRMC study was mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a "Tinnitus Sound Generator Module" embedded within a digital hearing instrument platform. It is designed to be used in conjunction with a "Tinnitus Management Program" and involves a healthcare professional for fitting and potentially remote fine-tuning.
While the module generates sounds (an algorithmic function), it is not described as a "standalone algorithm" in the typical sense of AI performing an independent diagnostic or predictive task. It functions as part of a system with human intervention (HCP fitting, patient use, remote adjustments).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the technical performance data, the "ground truth" refers to compliance with established engineering and safety standards (e.g., IEC standards for EMC) and the device's design input requirements. There is no mention of clinical outcomes data, pathology, or expert consensus being used as ground truth for a clinical study within this 510(k) summary. The summary focuses on demonstrating substantial equivalence through technical comparisons and verification activities.
8. The sample size for the training set
This is not applicable. The document describes a medical device, not a machine learning or AI model that typically requires a "training set" of data.
9. How the ground truth for the training set was established
This is not applicable, as there is no mention of a training set for a machine learning or AI algorithm.
§ 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.