(141 days)
Tinnitus SoundSupport is a tool intended to generate sounds to provide temporary relief to patients suffering from tinnitus as part of a tinnitus management program.
The target population is the adult population (>18yrs).
Tinnitus SoundSupport is targeted for licensed hearing care professionals (audiologists, hearing aid specialists, or otolaryngologists) who are familiar with the evaluation and treatment of tinnitus and hearing losses. The fitting of Tinnitus SoundSupport must be done by a hearing care professional participating in a tinnitus management program.
Oticon's Tinnitus SoundSupport consists of a software module added to the company's class II, 510(k)-exempt wireless air conduction hearing instruments legally marketed under 21 C.F.R. 874.3305. Tinnitus SoundSupport is fitted to the patient by the Hearing Care Professional using Oticon fitting software.
Tinnitus SoundSupport provides the option of relief sounds based on white, pink or red noise. The relief sounds can be limited in frequency by high pass or low pass filters. Tinnitus SoundSupport also provides the option of amplitude modulation, a volume control and automatic level steering.
The design of Tinnitus SoundSupport is based on the controls of the Occupational Safety and Health Administration (OSHA). Compliance with OSHA controls is achieved through (1) output limitation and (2) professional labeling and (3) patient labeling.
Tinnitus SoundSupport must be used as part of a tinnitus management program.
The provided text describes the Tinnitus SoundSupport device and its substantial equivalence to predicate devices, rather than a study with specific acceptance criteria and detailed performance data. The device's performance is primarily assessed through compliance with relevant standards and comparison to existing legally marketed devices.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative, measurable sense for clinical performance. Instead, performance is evaluated through compliance with various standards and by demonstrating substantial equivalence to predicate devices. The "reported device performance" is largely qualitative, indicating that the device "functioned as intended and the performance observed was as expected" in relation to these standards.
| Acceptance Criteria Category | Specific Standards/Criterion | Reported Device Performance |
|---|---|---|
| Software Functionality | IEC 62304 (Medical device software - Software life-cycle processes) | "Oticon's Tinnitus SoundSupport embedded software module and the Tinnitus tool in the fitting software has been verified and validated according to relevant standard for medical device software... In all instances, Oticon's Tinnitus SoundSupport functioned as intended and the performance observed was as expected." |
| Underlying Hearing Instrument Functionality | ANSI C63.19-2007 (Compatibility Wireless Communications Devices and Hearing Aids) | "In all instances, the 510(k)-exempt hearing instruments functioned as intended and the performance was as expected." |
| IEC 60118-13 (Electroacoustics - Hearing aids - Part 13: Electromagnetic compatibility (EMC)) | (Same as above) | |
| IEC 60601-1-2:2007 + Corrigendum 5/2010 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests) | (Same as above) | |
| IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) | (Same as above) | |
| ETSI 301 489-3 (Electromagnetic compatibility and Radio spectrum Matters (ERM); EMC standard for radio equipment and services; Part 3: Specific conditions for Short-Range Devices (SRD)) | (Same as above) | |
| ETSI 300 330-2 (Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Radio equipment in the frequency range 9 kHz to 25 MHz and inductive loop systems in the frequency range 9 kHz to 30 MHz Part 2: Harmonized EN under article 3.2 of the R&TTE Directive) | (Same as above) | |
| FCC 47 CFR Part 15 §15.109, §15.209, §15.223 (Title 47 of the Code of Federal Regulations; Chapter I Part 15 - Radio frequency devices - Radio frequency devices Operation in the band 1.705-10 MHZ) | (Same as above) | |
| ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process) | (Same as above) | |
| Safety and Effectiveness | Substantial Equivalence to Predicate Devices (K110932 - GnResound Tinnitus Sound Generator, K123450 - Phonak Tinnitus Balance Software) | "Oticon's Tinnitus SoundSupport is as safe and effective as GnResound's Tinnitus Sound Generator (K110932) and Phonak's Tinnitus Balance Software (K123450)." Minor technological differences do not present any new issues of safety or effectiveness. |
| OSHA Compliance (Output Limitation) | Occupational Safety and Health Administration (OSHA) controls | "Compliance with OSHA controls is achieved through (1) output limitation and (2) professional labeling and (3) patient labeling." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical performance study with a "test set" in the sense of patient data. The performance evaluations mentioned are related to software verification and validation, as well as electrical, EMC, and biocompatibility standards for the device's components. There is no mention of a sample size of patient data, nor its provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Since there is no "test set" of patient data with a ground truth established by experts, this information is not applicable and not provided in the document.
4. Adjudication Method for the Test Set
As there is no clinical "test set" of patient data, an adjudication method is not described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a MRMC comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. The device is a "Tinnitus Masker" and a software module integrated into hearing aids, not an AI-assisted diagnostic or interpretative tool for human readers.
6. Standalone (Algorithm Only) Performance Study
The document describes the performance of the embedded software module and the underlying hearing instruments as meeting relevant standards and functioning as intended. This can be considered a standalone performance evaluation in the sense that the software/device's technical performance was verified. However, it's not a clinical standalone study to assess its effectiveness in relieving tinnitus in patients independent of a human provider's intervention (which is explicitly required as part of a tinnitus management program).
7. Type of Ground Truth Used
For the software and hardware evaluations, the "ground truth" would be the specifications and requirements defined by the relevant standards (IEC 62304, ANSI C63.19-2007, IEC 60118-13, IEC 60601-1-2, IEC 60601-1, ETSI standards, FCC regulations, ISO 10993-1). The device's functionality was compared against these technical specifications.
For the substantial equivalence claim, the "ground truth" is established by comparing the device's indications for use, technological characteristics, and principles of operation to those of the legally marketed predicate devices, with the conclusion that "minor technological differences do not present any new issues of safety or effectiveness."
8. Sample Size for the Training Set
The document does not describe a machine learning algorithm that requires a "training set" of data. The device is a sound generator designed for tinnitus relief, and its functionality is based on established acoustic principles and software engineering, not on learning from a dataset.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for a machine learning algorithm, this question is not applicable.
§ 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.