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510(k) Data Aggregation
(114 days)
QUH
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.
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(109 days)
QUH
The WSA Self-Fitting Hearing Aid Gen 2 is intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. It is adjusted by the user to meet the user's hearing needs through software tools. The device is intended for direct-to-consumer sale and use without the assistance of a hearing care professional.
The SF-App is intended to support self-fitting and fine-tuning of the hearing aid.
The WSA Self-Fitting Hearing Aid Gen 2 ("SF Gen 2") is a self-fitting air conduction hearing aid 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.
The SF Gen 2 hardware includes: Earpieces (sleeves), housing, circuit board including a chip set running embedded software, antenna for near-field magnetic inductive wireless connection for data exchange between the left and right hearing aids, rechargeable battery, and electroacoustic components. The instant fit in-the ear (ITE) style of the hearing aids uses sleeves in 4 different sizes to couple with the ear canal. The sleeves are available in vented and closed styles. The hearing aids are powered by built-in rechargeable Lithium-lon batteries. The device includes embedded software that communicates with the self-fitting software app.
The SF Gen 2 self-fitting system consists of: (a) a wireless hearing aid with a self-fitting feature, and (b) a software application to support hearing aid self-fitting and fine tuning. The subject device is fitted for bilateral use. Left and right hearing aids can communicate with each other over a magnetic inductive wireless link, and the hearing aids communicate with the self-fitting web application (the "self-fitting app") using acoustic technology.
The SF Gen 2 self-fitting app is run on an Internet browser that is integrated into a software app that is downloaded onto and accessed through the user's mobile device. The self-fitting strategy begins with an acoustic profiling test that the user performs while wearing the hearing aids. Based on the user's hearing profile, a "cluster" of initial settings is applied to each hearing aid, and users are then guided through fine-tuning of these settings to self-fit the hearing aids for their particular needs and comfort. The mobile app also allows the user to adjust audiological gain parameters and preferred settings on the hearing aid, and functions as a remote control for adjusting hearing aid volume during daily use.
The provided text describes a 510(k) premarket notification for the "WSA Self-Fitting Hearing Aid Gen 2" and claims substantial equivalence to a predicate device, the "Vibe SF Self-Fitting Hearing Aid (K220403)".
While it mentions performance testing for various engineering properties, it explicitly states that "no new clinical performance testing was required." This means there is no detailed study described that establishes a specific acceptance criterion (e.g., in terms of hearing improvement or speech understanding) and then proves the device meets it through a clinical trial. Instead, the argument for safety and effectiveness is based on the device's substantial equivalence to a previously cleared predicate and non-clinical performance testing of its components.
Therefore, the requested information elements related to clinical study design (sample size, ground truth, expert opinions, MRMC, standalone performance) cannot be fully answered as these types of studies were not conducted or described for this specific submission as per the provided text.
Here's the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Property | Acceptance Criteria (Implied by Standards/Regulations) | Reported Device Performance (SF Gen 2) |
|---|---|---|
| Electrical Safety & EMC | Compliance with IEC 60601-1 Ed. 3.2:2020, IEC 60601-1-2 Ed. 4.1:2020, IEC 60601-1-11 Ed. 2.1:2020, IEC 60601-2-66 Ed. 3.0:2019 | Pass |
| Wireless Functionality & Coexistence | Compliance with AAMI TIR 69:2017, ANSI C63.27:2021 | Pass |
| Electroacoustic Performance | Compliance with ANSI/ASA S3.22:2014, ANSI/CTA 2051:2017, 21 CFR § 800.30 | Pass |
| Max OSPL 90 | Adequate for fitting moderate hearing loss (55 dB HL) as prescribed by NAL-NL2. (Predicate: 114 dB SPL) | 114 dB SPL |
| Fitted OSPL 90 | Adequate for fitting moderate hearing loss (55 dB HL) as prescribed by NAL-NL2. (Predicate: 103 dB SPL) | 99 dB SPL |
| Full-on gain | Adequate for fitting moderate hearing loss (55 dB HL) as prescribed by NAL-NL2. (Predicate: 45 dB) | 44 dB |
| Frequency Range | Adequate for fitting moderate hearing loss as prescribed by NAL-NL2. (Predicate: 100 – 8600 Hz) | 250 – 8000 Hz or 100-9100 Hz |
| Input Noise (Self-generated) | Comply to the required limit of 32 dB A per 21 CFR 800.30(e)(2). (Predicate: 20 dBA) | 23 dBA |
| Software Verification / Validation | Compliance with IEC 62304 A1:2016 | Pass |
| Battery Safety | Compliance with IEC 62133-2:2017, UL 1642:2014 | Pass |
| Risk Assessment | Compliance with ISO 14971:2019, AAMI TIR57:2016 | Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a clinical test set or patient data used for evaluation of the device's hearing performance. The "Performance Testing" section refers to non-clinical (engineering) tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical test set with human-established ground truth for hearing performance is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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
Not applicable. The device is a self-fitting hearing aid, not an AI diagnostic tool primarily evaluated with human readers. The submission explicitly states "no new clinical performance testing was required."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes non-clinical technical testing (e.g., electroacoustic performance, software validation) of the device's components and overall system. While these tests evaluate the "algorithm" or device's standalone performance in specific technical domains, it does not refer to "standalone performance" in the context of a clinical outcome that would typically be compared to human performance (e.g., a standalone AI diagnostic algorithm).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance tests, the "ground truth" or reference is typically the specified international standards and regulations (e.g., IEC, ANSI, CFR requirements). For example, electroacoustic performance is compared against the limits defined in ANSI/ASA S3.22:2014.
8. The sample size for the training set
Not applicable. The document does not describe the development or training of a machine learning model beyond the general mention of a "self-fitting strategy" which "integrates user input with a self-fitting strategy." It does not specify a separate training set for a machine learning algorithm.
9. How the ground truth for the training set was established
Not applicable, as no training set for a machine learning algorithm is described.
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(149 days)
QUH
The Soundwave Hearing Sontro® Self-Fitting OTC Hearing Aids are intended to amplify sounds for use by individuals 18 years and older with perceived mild to moderate hearing impairment. The device is intended for over-the-counter sale and use without the assistance of a hearing care professional.
Per 21 CFR 874.3325, a self-fitting wireless air-conduction hearing aid is a wearable soundamplifying device intended to compensate for impaired hearing. It incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy, enabling users to independently derive and customize their hearing aid fitting and settings. This is an over-the-counter hearing aid.
The Soundwave Hearing, Sontro® OTC (over-the-counter) Hearing Aids are self-fitting wireless air conduction hearing aids consisting of the hardware and software: the device uses the otoTune® app and accessories supplied in the carton. Each hearing aid in the pair functions and interacts with the otoTune® app independently and as a system.
A disposable size 312 zinc-air battery powers the hearing aids. The hearing aids incorporate microphones for audio input, and sound is delivered to the ear via a receiver in the canal that can be coupled with ear domes. The hearing aids are controlled via onboard button controls and wirelessly via the otoTune® app (iOS and Android). The controls allow the user to configure parameters, settings, and listening modes.
Here's a breakdown of the acceptance criteria and the study details for the Sontro® OTC Hearing Aids (AI), based on the provided document:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Endpoint) | Reported Device Performance | Non-inferiority Criterion Met? |
|---|---|---|
| Primary Effectiveness: | ||
| SELF-FIT REAR equivalent to CLINIC-FIT NAL/NL2 prescription REAR targets (in-lab) | Average REAR differences (CLINIC-FIT - SELF-FIT) for both ears: 0.17 dB. 95% CI: (-0.44, 0.78). | Yes (CI within +/- 5 dB) |
| SELF-FIT APHAB global score non-inferior to CLINIC-FIT APHAB global scores (wear-time field trial) | Average APHABglobal differences (CLINIC-FIT - SELF-FIT): 1.93. 95% CI: (-4.35, 8.21). | Yes (CI upper bound -1.5 dB) |
| SELF-FIT QuickSIN equivalent to CLINIC-FIT QuickSIN (wear-time field trial) | Average QuickSIN SNR loss differences (CLINIC-FIT - SELF-FIT): -0.06 dB. 95% CI: (-1.47, 1.36). | Yes (CI lower bound > -1.5 dB) |
| REAR for FINAL-FIT equivalent to REAR for AFTERTRIAL-FIT (wear-time field trial) | Average REAR differences (AFTERTRIAL-FIT - FINAL-FIT) for both ears: -0.22 dB. 95% CI: (-0.87, 0.42). | Yes (CI within +/- 5 dB) |
| Secondary Reliability: | ||
| SELF-FIT QuickSIN (A) equivalent to SELF-FIT QuickSIN (B) (in-lab) | Average QuickSIN SNR loss differences (SELF-FIT A - SELF-FIT B): 0.28 dB. 95% CI: (-0.48, 1.03). | Yes (CI lower bound > -1.5 dB) |
Study Details
-
Sample Size used for the test set and the data provenance:
- Sample Size: 29 participants were enrolled in the study (13 men, 16 women). 17 subjects withdrew due to poor compliance or personal reasons, meaning the final analysis was likely based on 12 participants.
- Data Provenance: The document does not explicitly state the country of origin but implies a single clinical study setting. It was a prospective study involving participants with perceived mild to moderate hearing impairment.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The "ground truth" for the test set in this context refers to the CLINIC-FIT measurements. These were established by an "audiology-best-practices hearing aid fitting," which implies fitting by a qualified audiologist. The document does not specify the exact number of audiologists or their years of experience but indicates adherence to "audiology-best-practices."
-
Adjudication method for the test set:
- The clinical study compared the device's self-fitting method (SELF-FIT) against a clinician-fitted method (CLINIC-FIT). There isn't an explicit "adjudication method" described in the sense of multiple experts reviewing cases. Instead, the "ground truth" (CLINIC-FIT) was established by standard audiological best practices. The comparison was statistical, assessing non-inferiority between the SELF-FIT and CLINIC-FIT results.
-
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, a traditional MRMC study comparing human readers with and without AI assistance was not explicitly stated or conducted as described. This study focuses on the effectiveness of a self-fitting hearing aid compared to a clinician-fitted hearing aid, not on AI assistance for human "readers" of medical images or data.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the "SELF-FIT" arm of the study represents the performance of the device's self-fitting algorithm without direct human (audiologist) intervention in the fitting process. The user themselves interacts with the app to perform the fitting. However, it's important to note that the user is "in the loop" for the self-fitting process, but an audiologist is not. So while not a fully "algorithm-only" standalone per se, it is standalone clinician-free fitting.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for comparison ("reference standard") was expert-established audiological measurements and patient-reported outcomes, specifically:
- Real-Ear Aided Response (REAR) based on audiology-best-practices NAL/NL2 prescription, representing an objective acoustic measure.
- Abbreviated Profile of Hearing Aid Benefit (APHAB) global scores, representing subjective patient outcomes.
- QuickSIN test results, representing an objective measure of speech recognition in noise.
- The ground truth for comparison ("reference standard") was expert-established audiological measurements and patient-reported outcomes, specifically:
-
The sample size for the training set:
- The document does not provide information regarding a specific training set size for the self-fitting algorithm. The focus of this submission is the clinical validation of the device itself, which incorporates the self-fitting technology. The development and training data for the underlying algorithm are not detailed here.
-
How the ground truth for the training set was established:
- As there is no information on a specific training set in the provided text, there is also no information on how the ground truth for such a set was established. It can be inferred that the NAL-NL2 fitting algorithm, which the device utilizes, is a widely validated and established prescriptive method in audiology, derived from extensive research and clinical data over time, rather than a specific "training set" for this particular device submission.
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(532 days)
QUH
The Self-Fitting hearing aids are intended to amplify sound for individuals 18 years of age or older with to moderate hearing impairment. They are adjusted by the user's hearing needs. The device is intended for use without the assistance of a hearing care professional.
Per 21 CFR 874.3325, a self-fitting wireless 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. 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. Self-Fitting hearing aids are controlled via button controls and wirelessly via the smart hearing app (iOS and Android). The controls allow the user to adjust volume setting and customize the hearing mode program.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance for Self-Fitting Hearing Aids (K221052)
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Metric | Acceptance Criteria (Non-Inferiority Margin) | Reported Device Performance (Confidence Interval / P-value) |
|---|---|---|---|
| Co-Primary Endpoints | REAG (Self-fit vs. Pro-fit) at 500Hz, 1000Hz, 2000Hz, 4000Hz (Lab) | -2.5 dB (non-inferiority margin) | - Right Ear: |
| 500Hz: (-1.7976, 0.8933), P |
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(260 days)
QUH
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 | ** |
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(109 days)
QUH
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.
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The Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application is a self-fitting air-conduction hearing aid, intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. The device is adjusted by the user to meet the user's hearing needs. The device is intended for use without the assistance of a hearing care professional.
The Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application is a self-fitting, air conduction hearing aid consisting of the IntriCon hardware, Lexie Software, Lexie Application and accessories supplied in the carton. The Lexie App is available on Android and iOS. The Lumen self-fitting OTC hearing aid is the only model applicable to this 510(k). The Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application is a behind the ear device that includes self-adjustable coupling by means of a slim tube and ear tip/dome. The hearing aids can be fine-tuned remotely by trained hearing experts, at the request of the user, in the Lexie contact center. The Lexie app receives custom remote settings as performed through the Lexie adjustment wizard and fitting portal (internet service).
Here's a breakdown of the acceptance criteria and the study details for the Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Category | Acceptance Criteria (from study) | Reported Device Performance (Lexie SF Group vs. AF Group) | Conclusion |
|---|---|---|---|
| Clinical Performance (Effectiveness) | |||
| Primary Endpoint: APHAB Global Benefit | (Implicit: Outcomes equivalent to AF group) | 2-weeks: SF group had less difficulty in background noise (p .05). All subscales within 1-point margin. Total score within 5-point margin. | Met |
| Secondary Endpoint: Speech-in-Noise (DIN) | 1.8 dB SNR acceptance criteria | 2-weeks: DIN aided scores poorer for AF group than SF (p .05) or calculated benefit scores. | Met |
| Safety | No Serious Adverse Events (SAEs) | One participant withdrew due to a middle ear infection (unrelated to device). No SAEs occurred. | Met |
| Human Factors Testing | Success rate > 79% on all use-related critical tasks | > 79% success rate on all use-related critical tasks. High user satisfaction (65.5% found it "easy to use" and "user-friendly"). One minor issue with slim tube size/domes not impacting safety. | Met |
| Non-clinical Performance Testing | (Each standard has its specific pass/fail criteria) | All tested standards (IEC 60601-1, IEC 60601-1-11, IEC 60601-2-66, IEC 60601-1-2, IEC 60118-13, ANSI/ASA S3.22, ANSI CTA 2051, ANSI ASA S3.6, IEC 62304, ISO 10993 series, IEC 60601-1-6, FDA Cybersecurity Guidance, IEEE / ANSI C63.27, ANSI C63.19) | Pass |
| ANSI ASA S3.22 (Acoustic Performance) | Max OSPL90: |
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The Eargo Self-Fitting Hearing Aids are intended to amplify and transmit sound to the ear and thereby compensate for perceived mild to moderate hearing impairment in individuals 18 years of age or older. They are adjusted by the user to meet the user's hearing needs. No pre-programming or hearing test is necessary. The product is intended to be used without the assistance of a hearing care professional.
The Eargo Self-Fitting Hearing Aid is a self-fitting air-conduction hearing aid system that incorporates wireless technology in its programming and use. The hearing aid system consists of a pair of earbud-style hearing aids (left and right), a charging case, and a companion mobile application (app) available for iOS (version 12 or later) and Android (version 7 or later) mobile devices. The hearing aids are designed to be virtually invisible, inserted completely and discreetly within the ear canal. Each hearing aid contains a microphone to allow for audio input, which is amplified by the hearing aid. The mobile app facilitates Eargo's proprietary self-fitting process using a combination of proprietary ultrasonic (for fitting) and Bluetooth Low Energy (BLE; for programming fitting settings) wireless communication. The mobile app also allows the user to control the hearing aids using proprietary ultrasonic wireless communication and enables firmware updates to the hearing aid system via BLE. App-based user controls include program and settings changes. In addition, each hearing aid contains an accelerometer sensor that allows for ondevice user control of the hearing aids. On-device user controls allow the user to make program changes without the mobile app. Each hearing aid contains a rechargeable Li-ion battery and is charged by the charging case that also functions as a carrying case. The charging case contains a single-cell Li-ion rechargeable battery, which charges the hearing aids via wireless (near-field inductive) charging when the hearing aids are correctly placed into the charging case.
Here's a breakdown of the acceptance criteria and the study details for the Eargo Self-Fitting Hearing Aids, based on the provided text:
Acceptance Criteria and Device Performance
The document doesn't explicitly present a single "Table of Acceptance Criteria" with numerical targets and direct "Reported Device Performance" for each criterion in the same way one might find for a pass/fail mechanical test. Instead, the acceptance criteria are embedded within descriptions of various tests, and the "reported device performance" is the successful conclusion (e.g., "Pass," "Comparable to predicate," "Acceptable usability and satisfaction").
However, I can extract the implicit acceptance criteria and the demonstrated performance where quantitative or qualitative measures are reported:
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Safety and General Performance (Compliance with Standards) | |
| FCC Title 47 CFR, subpart 15 subpart C (Intentional Radiators) | Pass |
| IEC 60601-1:2014 (Basic Safety & Essential Performance) | Pass |
| IEC 60601-2-66:2019 (Basic Safety & Essential Performance for Hearing Instruments) | Pass |
| IEC 60601-1-2:2014 (Electromagnetic Compatibility - EMC) | Pass |
| IEC 60118-13:2019 (Hearing Aid EMC) | Pass |
| ANSI ASA S3.22:2014 (Hearing Aid Characteristics - Electroacoustics) | Pass |
| IEC 62304:2006 (Software Lifecycle Processes) & FDA Guidance (Software Content of Premarket Submissions) | Pass (Software Verification and Validation) |
| ISO 10993-1, -5, -10, -12 (Biocompatibility) | Pass |
| IEC 62366:2007 + A1:2014 & IEC 60601-1-6:2010 + A1:2013 & FDA Guidance (Summative Usability / Human Factors Validation) | Pass |
| FDA Guidance (Cybersecurity Compliance) | Pass |
| ASTM D4169-16 & D7386-16 (Package & Transit Testing) | Pass |
| Electroacoustic Performance (Table 3) | |
| MAX OSPL 90 (less than 117 dB SPL per OTC HA requirements) | 106 dB SPL (less than 117 dB SPL) |
| HFA OSPL 90 (adequate for fitting mild-moderate HL as prescribed by NAL-NL2) | 104 dBSPL (Comparable to predicate, adequate for NAL-NL2) |
| HFA FOG (adequate for fitting mild-moderate HL as prescribed by NAL-NL2) | 26 dB (Comparable to predicate, adequate for NAL-NL2) |
| Reference Test Gain (RTG) (adequate for fitting mild-moderate HL as prescribed by NAL-NL2) | 26 dB (Comparable to predicate, adequate for NAL-NL2) |
| Frequency Range (suitable for intended use per OTC HA requirements) |
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The IQbuds 2 PRO 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 over the counter sale and use without the assistance of a hearing care professional.
The Nuheara IQbuds 2 PRO Hearing Aid (Model NU320) is a self-fitting wireless air conduction hearing aid (§ 874.3325) consisting of the hearing aids with Ear Tips. Charge Case, Nuheara software, the Nuheara app, and accessories supplied in the carton. The device is indicated for over-the-counter sale. The hearing aids are designed to be worn in both ears simultaneously with the appropriate size Ear Tips fitted to the sound port of the aid. The device has Ear ID, an innovative hearing assessment system that uses the NAL-NL2 unique programming formula designed for and used globally by hearing aid manufacturers. This hearing profile/personalization system in the IQbuds 2 PRO Hearing Aid assesses the individual's hearing levels across a frequency spectrum to customize the device's amplification specific to their hearing needs. In addition to hearing aid functionality for environmental and directive listening (using the microphones on the aids); the hearing aids can be used for making and receiving phone calls and for streaming audio from a Bluetooth®-compliant mobile device that has been paired with the Nuheara Hearing Aids.
Here's a breakdown of the acceptance criteria and the study that proves the Nuheara IQbuds 2 PRO Hearing Aid meets them, based on the provided document:
The document describes the performance of the Nuheara IQbuds 2 PRO Hearing Aid as part of its 510(k) premarket notification to the FDA, demonstrating its substantial equivalence to predicate devices. The studies primarily focus on usability and clinical performance to show effectiveness and safety.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list "acceptance criteria" in a clean table format with specific numerical targets for usability or clinical performance in the same way it does for electro-acoustic characteristics. Instead, the acceptance criteria for Usability and Clinical Performance appear to be demonstrated by showing that the device is safe and effective for its intended use by the target population and that its performance is comparable to established benchmarks or predicate devices.
For Electro-Acoustic Characteristics, the acceptance criteria are implicit: the device must meet or be within the established standards (ANSI S3.22 and CTA 2051:2017) and be comparable to the predicate device.
Implicit Acceptance Criteria and Reported Performance (derived from the text):
| Feature/Metric | Implicit Acceptance Criteria / Comparison Standard | Reported Device Performance/Study Findings |
|---|---|---|
| Usability | Device must be safe and effective for intended users to operate without professional assistance, demonstrating that identified use-related risks are mitigated. | Demonstrated that the device was safe and effective to operate by the intended user when used in accordance with its intended use. Usability was analyzed, verified, and validated; mitigations for user training and device labeling were adequate. No tasks identified as "critical," 3 deemed "essential" (warnings/cautions from User Guide) which implies these were addressed. |
| Clinical Effectiveness (Overall) | Device provides clinically meaningful benefit for individuals with perceived mild to moderate hearing impairment, comparable to established fitting algorithms (NAL-NL2) and reference devices/literature. | Quantitative Comparison (REIG vs. NAL-NL2): Ear ID™ provides acceptable margins of amplification, within ± 5 dB range, from prescribed targets (NAL-NL2), when averaged across the group. APHAB: Improved mean scores (lower scores) in aided condition for ease of communication in noise (17.8 points), in quiet (7.4 points), and in reverberation (8.2 points). Global improvement of 11 points. Unaided to Aided differences well within published 5-30% percentile norms. Outcomes consistent with studies using NAL-NL2 fit (e.g., Valente et al., 2018; Abrams et al., 2012). SSQ: Results (Speech: 7, Spatial: 7.1, Qualities: 7.2) were comparable to Valente study (Speech: 6.8, Spatial: 7.5, Qualities: 7.9) which used NAL-NL2 fit. Speech in Noise: 86% recall when directionality was employed, improving from 56% unaided or aided without directional microphone. |
| Electro-Acoustic Characteristics (examples) | Must meet ANSI/ASA S3.22 and CTA 2051:2017 standards, comparable to predicate. | Latency: 5ms (Predicate: ≤ 15 ms). Meets requirements, same as predicate. Frequency response: 200Hz - 8000 Hz (Predicate: 200Hz - 8000 Hz). Same as predicate. Input Distortion: ≤ 5% (measured 0.7%) (Predicate: ≤ 5%). Meets requirements, same as predicate. Equivalent Input Noise (EIN): 28.5 dB SPL (Predicate: 26 dB). Meets requirements, same as predicate. Harmonic Distortion: 0.2% (Predicate: ≤ 5%). Meets requirements, same as predicate. Max OSPL90: 109.6 dB SPL (Predicate: 115 dB SPL, Reference: 120 dB SPL). Meets requirements, same as predicate. HFA OSPL90: 100.9 dB SPL (Predicate: 112 dB SPL, Reference: 111 ± 2 dB SPL). Meets requirements, lower than predicate but does not introduce safety questions. HFA FOG: 29.4 dB SPL (Predicate: 43 dB, Reference: 40 ± 2 dB). Meets requirements, lower than predicate but does not introduce safety questions. RTG: 24.4 dB SPL (Predicate: 36 dB, Reference: 34 ± 4 dB). Meets requirements, lower than predicate but does not introduce safety questions. |
| Biocompatibility | Must meet ISO 10993 standards and not pose biological risks. | Passed all relevant non-clinical performance testing and biological endpoints: cytotoxicity (ISO 10993-05:2009), sensitization, and intracutaneous reactivity (ISO 10993-10:2010). |
| Electrical Safety, EMC, Battery Safety, Software | Must meet relevant IEC and ISO standards and FDA guidance, mitigating risks to an acceptable level consistent with predicate. | Passed all relevant non-clinical performance testing. Software developed, tested, and documented per IEC 62304:2006+A1:2015, FDA guidances (Software Contained in Medical Devices 2005, Cybersecurity in Medical Devices 2018). Demonstrated mitigation of risks to acceptable level and reasonable assurance of safe and effective non-clinical performance, consistent with predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Usability Testing:
- Sample Size: Eighteen (18) adults.
- Data Provenance: The study was conducted in a "quiet, comfortable room" for one-on-one sessions, implying a controlled, prospective study. The location is not explicitly stated (e.g., country of origin), but the context of an FDA submission for a US market suggests it was likely conducted in the US or in compliance with US regulatory standards.
- Clinical Performance Study:
- Sample Size: Forty-three (43) adults.
- Data Provenance: This was a "prospective investigation." Similar to usability, the exact country is not stated, but it's part of a US FDA submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not explicitly state the number or specific qualifications of experts used to establish ground truth for the test set in the same way one might expect for imaging studies.
- Usability Testing: "An independent, trained moderator conducted each session." It doesn't specify if experts established a 'ground truth' for whether a task was performed correctly beyond the scoring of completion by the moderator and review by a "cross-functional team."
- Clinical Performance Study:
- NAL-NL2 Reference: The "audiologist determined REM using standard audiologic practice (NAL-NL2)" serves as a direct ground truth. This implies audiologists were involved.
- Subjective Questionnaires (APHAB, SSQ): These are self-reported measures, so the "ground truth" is the participant's own perception, not expert-established.
- Speech in Noise: This involves objective performance (percent recall of sentences) vs. a known noise background.
- The "Ear ID feature... was developed and validated by National Acoustics Laboratories (NAL)." This indicates expert development of the core self-fitting algorithm.
No explicit mention of a "number of experts" for adjudication or ground truth per test case.
4. Adjudication Method for the Test Set
The document does not describe a formal "adjudication method" like 2+1 or 3+1, which is common in radiologic image interpretation studies.
- Usability Testing: Participants were "scored on status of completion of all steps in each of the tasks." A "cross-functional team reviewed outcomes at frequent intervals and addressed changes." This implies consensus or review, but not a specific adjudication protocol.
- Clinical Performance Study: The methods used (comparison to NAL-NL2, self-reported questionnaires, objective speech-in-noise tests) are direct measurements or comparisons against established audiological standards, not subject to typical human reader adjudication.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted in the traditional sense of human readers interpreting medical images with and without AI assistance. This device is a self-fitting hearing aid, not an AI for image interpretation.
The clinical performance study does compare the performance of the device's self-fitting method (Ear ID) to established audiological practices (NAL-NL2) and to the unaided condition, demonstrating clinical effectiveness. This serves a similar purpose of demonstrating effectiveness, but via audiological metrics rather than MRMC.
- Effect Size (Unaided vs. Aided performance from APHAB):
- Unaided to Aided difference in mean scores (lower is better):
- Ease of Communication (EC) in quiet: 7.4 points
- Reverberation (RV): 8.2 points
- Background Noise (BN): 17.8 points
- Global Score: 11 points
- These improvements were "well within the published 5-30 (%) percentile norms for the APHAB (Cox and Alexander, 1995)." The study also references Valente et al., 2018, which showed a significant median advantage of 4.2% for NAL-NL2 fitted subjects vs. manufacturer default fit for the background noise subscale problem score.
- Unaided to Aided difference in mean scores (lower is better):
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
Yes, the "Clinical Performance" study effectively assesses the standalone performance of the device's self-fitting algorithm (Ear ID) by:
- Quantitatively comparing target gain from the self-fit (Ear ID) to audiologist-determined NAL-NL2 REM targets. This is a direct measure of the algorithm's output against a gold standard.
- The entire premise of a "self-fitting" hearing aid is that the algorithm (Ear ID) performs the fitting function without professional human intervention in the loop.
7. The Type of Ground Truth Used
-
Clinical Performance:
- Expert Consensus/Standard Practice: For the quantitative comparison, the ground truth was "audiologist determined REM using standard audiologic practice (NAL-NL2)." This represents a professional, expert-established standard.
- User Performance/Subjective Outcomes: For the APHAB and SSQ, the ground truth is the individual participant's self-reported perception of their listening experience and sound quality. For Speech in Noise, it's the objective percentage of recalled sentences.
-
Usability Testing: The ground truth for task completion was based on the success/failure observed by a trained moderator against predefined task steps.
8. The Sample Size for the Training Set
The document does not specify a separate "training set" for the device's main self-fitting algorithm. The Ear ID system is described as using a "validated NAL-NL2 fitting algorithm" developed by National Acoustics Laboratories (NAL). NAL-NL2 is a widely recognized and established prescriptive formula for hearing aid fitting, not typically something a new device "trains" on in the machine learning sense. Instead, the device implements this algorithm.
If there were any machine learning components (e.g., for noise reduction or sound processing features), the training data for those are not disclosed in this document. The focus here is on the validation of the implementation of the NAL-NL2 principle and the device's overall performance.
9. How the Ground Truth for the Training Set Was Established
As noted above, there's no explicitly mentioned "training set" for the core self-fitting algorithm (Ear ID) in the machine learning sense that would require a separate ground truth establishment. The Nuheara IQbuds 2 PRO Hearing Aid utilizes the "validated NAL-NL2 fitting algorithm." The ground truth for NAL-NL2 itself (as a prescriptive target based on audiometric data) is an established audiological standard developed through extensive research and clinical validation by the National Acoustics Laboratories.
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