(114 days)
The Concha Sol Hearing Aids are intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. They are adjusted by the user to meet the user's hearing needs. No pre-programming or hearing test is necessary. The device is intended for use without the assistance of a hearing care professional.
The Concha Sol OTC Hearing Aids (Model CL-1001) are receiver-in-the ear, self-fitting, wireless air conduction hearing aids (§ 874.3325) intended to amplify sounds in the environment for adult users who have a perceived mild-to-moderate hearing loss. The hearing aids include Ear Tips, Carry Case and the Concha Labs mobile application. The device is indicated for over-the-counter sale (product code QUH) and integrates user input with a self fitting strategy, enabling users to independently derive and customize their hearing aid fitting and settings. Self-fitting wireless air-conduction hearing aids are Class II medical devices. The Self-Fitting hearing aids incorporate microphones for audio input, and sound is delivered to the ear via a receiver that can be coupled with domes. The mobile application contains a self-fitting software known as Soundscope, an innovative software that uses the NAL-NL2 programming formula used globally by hearing aid manufacturers. The hearing profile/personalization system in the Concha Sol Hearing Aid assesses the individual's hearing levels across a frequency spectrum in order to generate and customize the device's amplification specific to their hearing needs. The self-fitting software also assesses the individual's hearing preferences to help fine-tune the device's amplification. In addition to hearing aid functionality for environmental and directive listening; the hearing aids can also be used for telephony and streaming audio from a Bluetooth® compliant mobile device. The hearing aids are powered using Zinc Air size 312 cell batteries.
The Concha Sol Hearing Aids (CL-1001) were evaluated for their effectiveness and safety through a clinical study. The study objective was to assess the performance and clinical effectiveness of the self-fitting hearing aid using two distinct fitting methods: SELF-FIT (user-fitted with the Concha Labs App) and CLIN-FIT (clinically fitted by a hearing care professional).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Study Endpoint) | Target Performance (Margin) | Reported Device Performance (Concha Sol SELF-FIT vs. CLIN-FIT) | Outcome |
|---|---|---|---|
| Effectiveness: | |||
| Quick Speech-in-Noise (QuickSIN) | SELF-FIT outcomes comparable to CLIN-FIT within a margin of 1.8 dB for QuickSIN benefit | Not explicitly stated as numerical difference or statistical test result but indicated as "comparable performance" | Met: "For both assessed endpoints, the study results indicated comparable performance and satisfaction outcomes as revealed from clinical data as compared to the same hearing aid fit by a clinician." This implies the 1.8 dB margin was met or that the difference was not statistically significant beyond this margin. |
| Abbreviated Profile of Hearing Aid Benefit (APHAB) | SELF-FIT outcomes comparable to CLIN-FIT within a margin of 9.9 for APHAB | Not explicitly stated as numerical difference or statistical test result but indicated as "comparable performance" | Met: "For both assessed endpoints, the study results indicated comparable performance and satisfaction outcomes as revealed from clinical data as compared to the same hearing aid fit by a clinician." This implies the 9.9 margin was met or that the difference was not statistically significant beyond this margin. |
| Safety: | No device-related or other adverse events | No device-related or other adverse events observed | Met: "No device-related or other adverse events were observed over the course of the study. Also, no health-related issues due to device fit or discomfort were observed, and no device failures leading to potential safety issues were observed." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 21 participants (13 men, 8 women).
- Data Provenance: The document does not explicitly state the country of origin. The study design ("within-subject, randomized, crossover study design of the clinical investigation") suggests it was a prospective clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: The document details the "CLIN-FIT" method, which involved fitting by a "hearing care professional." It does not specify the number of individual hearing care professionals involved or their specific qualifications (e.g., years of experience).
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable in the traditional sense for these endpoints. The study compared two fitting methods (self-fit vs. clinician-fit) within the same subjects, using standardized objective (QuickSIN) and subjective (APHAB) outcome measures. The "ground truth" for the CLIN-FIT condition was established by the hearing care professional's fitting, which was then used as a reference for comparison.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC comparative effectiveness study was not explicitly described. The study design was a "within-subject, randomized, crossover study" to compare the performance of the Concha Sol device under two different fitting methods (SELF-FIT vs. CLIN-FIT). While human readers (users and a clinician) were involved in the fitting process and perception, it was not framed as an MRMC study comparing interpretations of diagnostic cases.
- Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable, as this was not a diagnostic AI study. The "AI" component would be the self-fitting software (Soundscope), which the users interact with directly. The comparison was between user-driven fitting and clinician-driven fitting of the same device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No, a standalone (algorithm only) performance study was not explicitly described for clinical effectiveness. The clinical study inherently involved human feedback and interaction (either by the user for SELF-FIT or by the clinician for CLIN-FIT). The Soundscope software's performance was evaluated as part of the overall device system in conjunction with human use. Electroacoustic testing provided standalone performance metrics for the hardware and general sound processing, but not specifically for the self-fitting algorithm's clinical outcomes without human interaction.
7. Type of Ground Truth Used
- Ground Truth: The study used the performance of the device when fitted by a hearing care professional (CLIN-FIT) as a reference "ground truth" for comparison against the user's self-fitting (SELF-FIT) results. This is an expert-derived benchmark using established clinical practices.
- QuickSIN: Objective measure of speech communication in noise.
- APHAB: Subjective measure of hearing impairment and benefit in daily life.
- Safety: Directly observed adverse events and health-related issues.
8. Sample Size for the Training Set
- Not Applicable / Not Provided: The document describes a clinical validation study for the Concha Sol device. It does not mention a separate "training set" for the self-fitting algorithm. The Soundscope software uses the NAL-NL2 programming formula, which is an established, globally used, prescriptive target rule for hearing aid fitting, implying its development and "training" occurred much earlier and separately from this device-specific validation.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable / Not Provided: As noted above, the document does not describe a training set for the self-fitting algorithm within the context of this submission. The NAL-NL2 (National Acoustic Laboratories - Nonlinear 2) formula, which the Soundscope technology utilizes, is a well-established prescriptive method in audiology. Its "ground truth" (i.e., its derivation and validation) would stem from extensive research, clinical trials, and epidemiological data in hearing science involving human perception, speech intelligibility, and comfort over many years, conducted by the National Acoustic Laboratories (Australia) and other research institutions. This is a foundational audiological principle rather than a training set specifically for this device's algorithm.
§ 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.