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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

2. Sample sizes used for the test set and data provenance

STUDY 1 (Clinical Performance Validation):

• Sample Size: 30 participants (adults).
• Data Provenance: Retrospective or Prospective is not explicitly stated as a separate point; however, the study design section states it was a "prospective, crossover, comparative study." The recruitment from "private hearing clinics" suggests the data is likely sourced from the country where these clinics are located, but the country of origin is not explicitly stated.

STUDY 2 (Subjective Outcome Comparison - COSI/IOI-HA):

• Sample Size: 41 participants (N=41 completed the study: 20 in Group 1, 21 in Group 2).
• Data Provenance: "Prospective, two-arm, two-site, crossover randomized controlled and comparative study." Similar to Study 1, the country of origin is not explicitly stated. Given the context of FDA submission, it's typically assumed to be North America or Europe unless otherwise specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

STUDY 1:

• Number of Experts: Not explicitly specified as a distinct number, but the study compared the Tuned self-test to "traditional audiometry performed by a professional" and "licensed audiologist." This implies at least one, if not multiple, qualified professionals.
• Qualifications of Experts: "Licensed audiologist" and "professional." No specific experience (e.g., "10 years of experience") is mentioned.

STUDY 2:

• Number of Experts: Not explicitly stated as a distinct number. The study compared self-fitting to "licensed professional fitting." This implies the involvement of one or more licensed professionals to perform the "professional fitting."
• Qualifications of Experts: "Licensed professional." No specific experience mentioned.

4. Adjudication method for the test set

The provided text does not mention any adjudication method for the test sets in either Study 1 or Study 2. The comparisons are direct between the device's output/self-fitting outcome and the professional's assessment/fitting outcome.

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

An MRMC comparative effectiveness study was not explicitly described in the provided text. The studies focus on comparing the self-fitting hearing aid's performance/user outcomes against traditional audiology methods, rather than assessing how human readers (e.g., radiologists, ophthalmologists) improve with AI assistance. The device is a self-fitting hearing aid, not an AI-powered diagnostic imaging tool that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, in essence, standalone performance was assessed for the self-fitting capability.

• Study 1 directly compared the "Tuned self-test" (algorithm-driven self-assessment) against "traditional audiometry performed by a professional" for auditory thresholds. This can be considered a form of standalone evaluation for the audiometric threshold detection aspect of the device's algorithm.
• The "Intrisound™ Tuned Lumen® 155 Hearing Aid is a wireless, self-fitting air conduction hearing aid... 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." This describes the core standalone functionality of the device's self-fitting algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Study 1: The ground truth for audiometric thresholds was established by traditional audiometry performed by a licensed professional (audiologist). For fitting parameters (NAL-NL2 targets, REAR), the ground truth was based on established audiology standards and professional fitting methods.
• Study 2: The ground truth for subjective outcomes was established using validated patient-reported outcome measures (PROMs) - COSI and IOI-HA questionnaires completed by the participants themselves, after using both self-fitting and professional fitting methods. This is a form of user-reported outcomes data. The "professional fitting" condition serves as a comparative reference for the self-fitting's effectiveness.

8. The sample size for the training set

The document does not specify the sample size for the training set used to develop the proprietary algorithm or the Tuned self-test. The studies described are performance validation/testing studies, not algorithm development studies.

9. How the ground truth for the training set was established

Since the training set size or methodology is not detailed, the document does not provide information on how the ground truth for the training set was established.

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