(260 days)
Intrisound™ Tuned Lumen® 155 are self-fitting, wireless air conduction hearing aids, intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. They are to meet the user's hearing needs. The device is intended for use without the assistance of a hearing care professional.
The Intrisound™ Tuned Lumen® 155 Hearing Aid is a wireless, self-fitting air conduction hearing aid. It features digital signal processing (16 channel wide dynamic input compression, 3 layer fastacting output compression, 16 channel noise reduction, feedback cancellation), bi-directional microphone with windscreen, volume and program control, 12 band equalizer, self-selectable tube and ear tips, and customization through the Tuned Mobile Application. The Tuned Mobile Application aims to detect accurate auditory thresholds, partnering with a smart phone application to deliver user-customized sound through the Intrisound™ Tuned Lumen® 155 Hearing Aid. These thresholds are used to program the device using a proprietary algorithm.
The provided text describes the acceptance criteria and the studies conducted for the Intrisound™ Tuned Lumen® 155 Hearing Aids.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a single, consolidated table specifically labeled "Acceptance Criteria and Reported Device Performance" in the typical format of a summary table for a medical device. However, the STUDY 1 section clearly outlines acceptance criteria for various endpoints and then immediately follows with the reported results for those criteria. Similarly, Table 2 and Table 3 detail performance characteristics against standards.
Let's synthesize the information specifically from STUDY 1 and relevant tables:
Acceptance Criteria and Reported Device Performance for Intrisound™ Tuned Lumen® 155 Hearing Aids
| Acceptance Criteria (Study 1, Section 10) | Reported Device Performance (Study 1 Results) |
|---|---|
| Mean Absolute Difference (MAD) of less than 10 dB for each tested frequency (500, 1000, 2000, 4000 Hz) between Tuned self-test and traditional audiometry. | Total MAD (averaged over all tested frequencies) was 5.25 dB (95% CI: 4.73 to 5.78 dB), which is well within 10 dB. Frequencies were well correlated. |
| Total MAD of less than 10 dB between Tuned self-test and traditional audiometry. | Total MAD was 5.25 dB (95% CI: 4.73 to 5.78 dB), well within 10 dB. |
| Tuned self-fitting is non-inferior to professional fitting by showing that the MAD from NAL-NL2 targets per frequency of the Tuned self-fitting is within the range of 5 dB of the MAD from NAL-NL2 of the professional fitting. | The MAD from NAL-NL2 per frequency of the Tuned self-fitting is well within the range of 5 dB of the MAD from NAL-NL2 of the professional fitting. |
| The total MAD from NAL-NL2 targets of the Tuned self-fitting is within the range of 5 dB. | The total MAD from NAL-NL2 targets for Tuned self-fitting is 3.37 dB (95% CI: 3.2 to 3.53 dB), well within 5 dB. |
| The total MAD of the Real Ear Aided Responses (REAR) of the Tuned self-fitting and the professional fitting is in the range of 5 dB. | The total MAD between the REAR of professional-fitting and Tuned self-fitting is 3.72 dB (95% CI: 3.55 to 3.89 dB), well within 5 dB. |
| The maximum power output (MPO) measurements do not exceed 117 dB SPL in any volume control level. | All MPO measurements in the real ear were less than 117 dB SPL in all volume control levels. |
| Additional Performance Characteristics (from Table 2 & Table 8: ANSI ASA S3.22 Performance Data) | Reported Device Performance |
| Max OSPL90 (for OTC hearing aids per 21CFR800.30) | 114.4 dB SPL (Lower than predicate's 120 dB SPL to comply with OTC requirements) |
| High Frequency Average OSPL90 (HFA OSPL90) | 109.6 ± 2 dB SPL (Meets requirements of the standard) |
| High Frequency Average Full-on Gain (HFA FOG) | 40 ± 2 dB (Meets requirements of the standard) |
| Reference Test Gain (RTG) | 34 ± 4 dB (Meets requirements of the standard) |
| Frequency Response | 200 Hz to 8000 Hz (Meets requirements of the standard) |
| Frequency Range | ** |
§ 874.3325 Self-fitting air-conduction hearing aid.
(a)
Identification. A self-fitting air-conduction hearing aid is a wearable sound amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings. A self-fitting air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical data must evaluate the effectiveness of the self-fitting strategy.
(2) Electroacoustic parameters, including maximum output limits, distortion levels, self-generated noise levels, latency, and frequency response, must be specified and tested.
(3) Performance data must demonstrate the electromagnetic compatibility (EMC), electrical safety, and thermal safety of the device.
(4) Software verification, validation, and hazard analysis must be performed.
(5) If the device incorporates wireless technology:
(i) Performance testing must validate safety of exposure to non-ionizing radiation; and
(ii) Performance data must validate wireless technology functions.
(6) Usability testing must demonstrate that users can correctly use the device as intended under anticipated conditions of use.