(109 days)
The All-Day Clear Slim hearing aids are intended for individuals 18 years or older with perceived mild to moderate hearing loss. The intended use of the All-Day Clear Slim hearing aids is to amplify and transmit sound to the ears and hereby compensate for hearing loss. The hearing aids must only be used by the intended person. They should not be used by any other person as they could damage hearing. The charging case is intended to charge the battery of the rechargeable hearing aids. The All-Day Clear App is intended for individuals 18 years or older, to set-up and/or adjust All-Day Clear Slim hearing aids through Android and Apple iOS smartphones.
The All-Day Clear hearing aids are intended for individuals 18 years or older with perceived mild to moderate hearing loss. The intended use of the All-Day Clear hearing aids is to amplify and transmit sound to the ears and hereby compensate for hearing loss. The hearing aids must only be used by the intended person. They should not be used by any other person as they could damage hearing. The charging case is intended to charge the battery of the rechargeable hearing aids. The All-Day Clear App is intended for individuals 18 years or older, to set-up and/or adjust All-Day Clear hearing aids through Android and Apple iOS smartphones.
The All-Day Clear Slim ADCS1 hearing aid and All-Day Clear ADC1 hearing aid are self-fitting air-conduction hearing aids. The ADCS1 and ADC1 hearing aids are nearly identical except for minor design differences. The hearing aid system consists of hearing aids for left and right ears, charging case, charging cable with USB-A and USB-C connector, wall plug, a set of eartips (small, medium, and large sizes), cleaning brush, carrying case (for ADCS1 hearing aids alone), and wax guards. The ADCS1 and ADC1 hearing aids are indicated for over-the-counter use.
The end user can self-fit the hearing aid by downloading the All-Day Clear App to their Android or Apple iOS device, pairing the hearing aids to the App, and following a series of guided onboarding steps:
- Instructions on how to wear the hearing aids
- Creation of a sound profile by listening to sample audio in which the user selects parameters for volume and sound clarity
- Selection of sound balance
Once the hearing aids have been set up with a sound profile, the App can continue to be used as a remote control of the hearing aids. For example, the end users can use the App to change the volume or mute the hearing aid microphones (together or independently), switch between different hearing aid sound modes, adjust the volume of a streamed signal, adjust equalizer and wind noise control, and read out the status of the hearing aid charge level.
The ADCS1 and ADC1 hearing aid system provides an alternative optional method of fitting the device by letting the end users purchase "In-Clinic Care Package", where they can have a licensed hearing care professional fit their hearing aids using professional fitting software called "All-Day Clear Fitting Software." All-Day Clear Fitting Software is a component of Sonova's TrueFit 5.3 or higher fitting software which can only be used by a licensed hearing care professional. In both scenarios, the end users can use the App as a remote control of the hearing aid.
Here's a breakdown of the acceptance criteria and study details based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Endpoint) | Non-inferiority Margin | Reported Device Performance (Self-Fit vs. Pro-Fit) | Conclusion on Acceptance Criteria Met? |
|---|---|---|---|
| Primary Effectiveness Endpoint: | |||
| APHAB Global Benefit Score (Self-Fit) | Not more than 12.5% below Pro-Fit | Adjusted mean treatment difference: 0.6% (95% CI: -2.919% to 4.742%) (after outlier exclusion) | Met (Lower bound > -12.5%) |
| Secondary Effectiveness Endpoint: | |||
| QuickSiN Benefit Score (Self-Fit) | -1.8 dB or higher | Adjusted mean treatment difference: 0.103 dB SNR (95% CI: -0.867 to 1.074 dB SNR) (Period 1 data) | Met (Lower bound > -1.8 dB) |
| Safety Endpoint: | (Implicit: No serious adverse events or unacceptable adverse events) | One non-serious treatment-emergent adverse event (ear canal occlusion, not device-related). No serious adverse events. | Met |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- Clinical Study: 44 participants (enrolled). Due to early discontinuations and outlier exclusion, analysis for effectiveness endpoints was based on varying numbers:
- APHAB: 40 participants (after excluding 2 outliers from the original 42 for Period 1 analysis).
- QuickSiN: 40 participants (Period 1 data analysis).
- Human Factors/Usability Study: 30 participants (15 patients, 15 caregivers).
- Clinical Study: 44 participants (enrolled). Due to early discontinuations and outlier exclusion, analysis for effectiveness endpoints was based on varying numbers:
- Data Provenance: Retrospective from clinical study performed with "HelloGO" hearing aid, which is stated to have identical hardware and almost identical firmware to the subject devices (ADCS1, ADC1). The human factors study was prospective, conducted specifically for the ADCS1/ADC1. The country of origin for the clinical study is not explicitly stated in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The clinical study did not involve AI assistance, therefore "ground truth" was established through direct measurement of human hearing abilities and perceptions using standardized audiological tests (APHAB and QuickSiN) with both self-fitted and professionally fitted devices.
- Professionally Fit Devices: Implies fitting by audiologists or hearing care professionals, but the specific number or qualifications of these professionals for establishing the "ground truth" (the professional fit as a comparator) are not detailed beyond "professional fitting method."
4. Adjudication Method for the Test Set
- Clinical Study (Effectiveness Endpoints): Not applicable in the sense of expert adjudication of a device's output. The study design involved direct comparison of patient-reported outcomes (APHAB) and objective speech-in-noise testing (QuickSiN) under two different fitting conditions (self-fit vs. professional fit). The "ground truth" for the benefit scores was derived directly from participant responses and test results.
- Human Factors/Usability Study: "Study staff systematically assessed device usage to identify problems that were encountered by participants, including use errors and close calls during participant performance." This suggests observation and recording of events, rather than a formal expert adjudication of discrete findings.
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
- No, an MRMC comparative effectiveness study was not done. This study focuses on the effectiveness of a self-fitting hearing aid compared to a professionally fitted one, not on AI assistance for human readers/clinicians.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, in a sense, the "self-fitting" method can be considered a standalone performance of the algorithm (as implemented in the app) plus the user's interaction, without a hearing care professional in the loop for the fitting process itself. The study compared this "self-fitted" performance to a "professionally fitted" performance.
7. The Type of Ground Truth Used
- Clinical Study (Effectiveness):
- Patient-Reported Outcomes: Abbreviated Profile of Hearing Aid Benefit (APHAB) global benefit score.
- Objective Audiological Measure: Quick Speech-in-Noise (QuickSiN) test benefit score.
- The "ground truth" for comparison was the outcome achieved with a professionally derived fitting.
- Safety: Tabulation of adverse events and serious adverse events.
- Human Factors/Usability: Observed use errors and close calls in a simulated environment, and participant feedback.
8. The Sample Size for the Training Set
- The document does not explicitly mention a "training set" for the clinical study parameters. The study design is a comparative effectiveness study between two fitting methods (self-fit and professional fit) for the hearing aid itself. The "self-fitting algorithm" embedded in the app would have had its own development and possible internal training process, but details of this are not provided in the context of this FDA summary.
- The human factors study did not involve a training set; it was a usability validation.
9. How the Ground Truth for the Training Set Was Established
- As a training set for the specific self-fitting algorithm is not detailed, the method for establishing its "ground truth" (e.g., what data it was trained on to achieve optimal fitting) is not provided in this document. The clinical study established ground truth for effectiveness comparison by using a professionally fitted condition as a benchmark.
§ 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.