(161 days)
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) than AF group. 6-weeks: No significant differences between SF and AF groups for any APHAB scores (unaided, aided, benefit). Scores fell within the 16.3 acceptance criteria for equivalence. | Met |
| Secondary Endpoint: IOI-HA Outcomes | 1-point margin for subscales (ordinal scales) | 2-weeks: SF group reported significantly longer duration of hearing aid use per day (p < .05). Significant difference in total score (p < .05). All subscales within 1-point margin. Total score within 5-point margin. | Met |
| 5-point margin for total score | 6-weeks: No significant differences between groups for any subscales or total score (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), but within 1.8 dB SNR criteria. Benefit scores not significantly different. | Met |
| (Implicit: Outcomes equivalent to AF group) | 6-weeks: No significant differences for aided QuickSIN or DIN tests (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: <120dB SPL | Measured 114.4dB SPL | Met |
| HFA-OSPL90: 111 ± 2dB SPL | 110dB SPL | Met | |
| HFA-FOG: 40 ± 2dB | 45dB | Met | |
| Reference Test Gain (RTG): 34 ± 4dB | 34dB | Met | |
| Frequency Response: 200Hz to 8000Hz (lower cutoff to 200Hz, upper to 5kHz+) | 200Hz to 7000Hz | Met | |
| Harmonic Distortion: ≤ 1.5% @ 500Hz, ≤ 2.0% @ 800Hz, ≤ 3.0% @ 1600Hz (overall <5%) | THD@ 500Hz: 0.4%, THD@ 800Hz: 0.2%, THD@ 1600Hz: 0.4% (all <5%) | Met | |
| EIN: <32 dB SPL | Actual measured value 26.4dB SPL (<32dB SPL) | Met | |
| Latency: <15ms | <15ms | Met |
2. Sample Size Used for the Test Set and Data Provenance
- Clinical Study:
- Sample Size: 64 participants (32 in the Audiologist Fit (AF) group, 32 in the Self-Fit (SF) group).
- Data Provenance: Prospective, Randomized Controlled Trial conducted at the University of Pretoria, Gauteng, South Africa.
- In-situ Hearing Test Accuracy Validation (separate study):
- Sample Size: 45 participants (90 ears).
- Human Factors Testing:
- Sample Size: 29 adult participants.
- Data Provenance: Simulated-use session, likely within a controlled environment (e.g., laboratory).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Clinical Study:
- The "ground truth" for the Audiologist Fit (AF) group was established by audiologists who performed standard audiometric evaluations and fitted the hearing aids to match NAL-NL2 prescriptive targets. The text doesn't specify the exact number of audiologists, but refers to "the audiologist" (singular) in descriptions of procedures, implying at least one qualified audiologist was involved in the fitting and orientation for the AF group. The context of a university setting (University of Pretoria) suggests these would be qualified professionals.
- For the in-situ hearing test validation, "the audiologist-performed audiometry" was used as a reference, again implying qualified audiologist(s).
- Human Factors Testing:
- No specific experts are mentioned as establishing "ground truth" in the same way as the clinical study. Instead, the "effectiveness and accuracy of the tasks" were assessed by observing participants' performance during simulated use, implying assessment by human factors specialists or researchers.
4. Adjudication Method for the Test Set
- The clinical study was a randomized controlled trial (RCT) comparing two groups (SF vs. AF).
- No explicit "adjudication method" (like 2+1 or 3+1 for expert review) is mentioned for the outcomes of the clinical study, as the primary and secondary endpoints (APHAB, IOI-HA, QuickSIN, DIN) are quantitative measures.
- For the in-situ hearing test accuracy, performance (Mean Absolute Difference) was compared against "audiologist-performed audiometry," where the audiologist's results served as the reference.
- For Human Factors Testing, an "observer" evaluated task success, and a "semi-structured interview" was used for user perceptions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- Yes, a comparative effectiveness study was done, comparing the Lexie Lumen in a self-fit (SF) condition against an audiologist-fit (AF) condition. This is a direct comparison of the device's performance with and without expert assistance in fitting.
- Effect Size of Human Readers Improve with AI vs. without AI assistance:
- The study compares self-fitting (device with its AI/software-driven fitting strategy) to audiologist-fitting (human expert). It doesn't present an effect size of "human readers improve with AI vs. without AI assistance" in the context of interpretation of medical images.
- Instead, it evaluates if the self-fitting strategy (which is AI/software-driven) is non-inferior to an audiologist's fitting. The results show that the SF group was equivalent or even slightly better in some aspects (background noise difficulty at 2 weeks, duration of use at 2 weeks) compared to the AF group, and overall achieved equivalence within the defined acceptance criteria for the primary and secondary endpoints. This implies that the device's self-fitting capability largely negates the need for a human professional's direct fitting intervention for achieving comparable outcomes for mild to moderate hearing loss.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, the "Self-Fit (SF) group" in the clinical study represents the standalone performance of the device's self-fitting algorithm without human-in-the-loop fitting assistance. Participants in this group were explicitly stated to "set up and manage the devices using the Lexie app, entirely without professional support." Any assistance sought in Phase II was through the Lexie online hearing experts, but the initial fitting and core performance were self-directed via the app's algorithm.
7. The Type of Ground Truth Used
- Clinical Study (Effectiveness):
- The ground truth was established by comparison with best-practice audiological fitting (NAL-NL2 targets) performed by audiologists. The aim was to demonstrate non-inferiority or equivalence against this established clinical standard.
- For the in-situ hearing test, the "Reference" was audiologist-performed audiometry.
- Safety:
- "Ground truth" for safety was the occurrence and nature of Adverse Events (AE) and Serious Adverse Events (SAE), which are reportable objective events.
- Human Factors Testing:
- "Ground truth" was the observational assessment of task completion and accuracy by study personnel, corroborated by user self-reports and satisfaction.
- Non-clinical Performance Testing:
- "Ground truth" was defined by the acceptance criteria within the cited national and international consensus standards (e.g., IEC, ISO, ANSI, CTA), against which the device's physical and electrical properties were measured.
8. The Sample Size for the Training Set
- The document does not provide information on the sample size for the training set used to develop the Lexie self-fitting algorithm or its core software. This information is typically proprietary and not usually disclosed in a 510(k) summary, which focuses on validation rather than development.
9. How the Ground Truth for the Training Set Was Established
- The document does not provide information on how the ground truth for the training set was established. The text only states that the fitting algorithm (Lexie Comfort) is "based on National Acoustics Laboratories' Non-Linear Version 2 (NAL-NL2), with additional adjustments aimed for a greater listening comfort." This implies that the NAL-NL2 prescriptive targets likely form a significant part of the foundational "ground truth" or reference for the algorithm's development, but details of specific training data and its ground truth are absent.
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May 4, 2023
hearX SA (Pty) Ltd. Seline Van Der Wat Chief Operations Officer Building 2, Ashlea Gardens Office Park, 180 Garsfontein Road, Ashlea Gardens Pretoria, 0081 South Africa
Re: K223137
Trade/Device Name: Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application Regulation Number: 21 CFR 874.3325 Regulation Name: Self-fitting Air-conduction Hearing Aid Regulatory Class: Class II Product Code: QUH
Dear Seline Van Der Wat:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated March 14, 2023. Specifically, FDA is updating this SE Package as an administrative correction to the 510(k) Summary.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Shu-Chen Peng, OHT : Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices, 301-796-6481, Shu-Chen.Peng@fda.hhs.gov.
Sincerely,
Shuchen Peng -S
Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Image /page/1/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol is a stylized representation of a human figure, and the text is in blue. The logo is simple and clean, and it is easily recognizable.
March 14, 2023
hearX SA (Pty) Ltd. Seline Van Der Wat Chief Operations Officer Building 2, Ashlea Gardens Office Park, 180 Garsfontein Road, Ashlea Gardens Pretoria, 0081 South Africa
Re: K223137
Trade/Device Name: Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application Regulation Number: 21 CFR 874.3325 Regulation Name: Self-Fitting Air-Conduction Hearing Aid Regulatory Class: Class II Product Code: QUH Dated: February 1, 2023 Received: February 1, 2023
Dear Seline Van Der Wat:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shuchen Peng -S
Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K223137
Device Name
Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application
Indications for Use (Describe)
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 thearing needs. The device is intended for use without the assistance of a hearing care professional.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
1. SUBMITTER
Name: hearX SA (Pty) Ltd Address: Building 2, Ashlea Gardens Office Park, 180 Garsfontein Road, Ashlea Gardens, Pretoria, South Africa, 0081 Establishment Registration Number: 3014337591 Contact Person: Seline van der Wat, Chief Operations Officer, Senior Director of Requlatory. Governance & Intelligence Phone: +27 12 030 0268 Email: Compliance@hearxgroup.com Date Prepared: 26 September 2022
2. SUBJECT DEVICE
Name of Device: Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application Common or Usual Name: Hearing Aid Classification Name: Self-Fitting, Air-Conduction Hearing Aid, Over the Counter (21 CFR 874.3325) Regulation Class: Class II Product Code: QUH Assigned K-number: K223137
3. PREDICATE DEVICE
Braun® Clear™ Hearing Aid BHA100 Series (K212609) This predicate device has not been subject to a design-related recall.
4. DEVICE DESCRIPTION
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.
Device Characteristics
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).
Environment for Use
The Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application are to be used in a Home Healthcare Environment. Any environment where personnel with medical training are
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not continually available to oversee or administer the use of medical devices. This includes, but is not limited to, outdoor environments, office environments, schools, vehicles, emergency shelters, and independent living retirement homes.
Brief Description
The Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application is designed for a single user. Once the hearing aids are switched on, the software (Lexie app) is required for the initial set-up of the hearing aids. The software can then be used to manage the day-today use of the hearing aids. The Lumen is a slim tube style, behind-the-ear, nonrechargeable hearing aid intended to be used for perceived mild to moderate hearing impairment. The hearing aid is intended to be used with the Lexie App and to be worn and removed daily by the end user.
Materials of Use
The hearing aid makes long term/permanent contact with the skin in and around the ear. The body of the hearing aid rests on the outer shell of the ear (behind the ear) and is coupled to a dome via a slim tube that is worn inside of the ear canal. The hearing aid is intended to be used with the Lexie App and to be worn and removed daily by the end user.
The materials used in the construction of the Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application are biocompatible presenting no biological risk; thus, the requirements of ISO 10993-1 have been met.
Key Performance Specifications
The hearing aids are used with a replaceable, disposable, 1.45V, size 312 zinc air battery. The digital signal processing on the hearing aids allows for the following features to be adjustable: 16 channel-wide dynamic range compression channels, 16 frequency bands, noise reduction, feedback cancellation, wind noise suppression, low level expansion and microphone arrays (adaptive and fixed microphone directionality).
5. INTENDED USE / INDICATIONS FOR USE
The Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application is a self-fitting airconduction 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.
6. LABELING
Self-Selection Labeling has been included in the Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application product label and Instructions for Use (IFU) to mitigate the risk of improper self-selection. Summarized, it addresses the following:
- ldentifying situations in which the Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application may help users hear better;
- ldentifying situations in which the Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application may not be right for users.
- -Identifying criteria that indicate users should see a hearing professional.
- -Informing users that the Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application will not restore normal hearing.
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- Informing users that it is good health practice to have hearing loss evaluated by a licensed healthcare professional.
7. SPECIAL CONTROLS
The Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application conforms to the special controls stated in 21 CFR 874.3325.
These requirements are satisfied through following:
- Clinical Performance Validation .
- Non-clinical Performance Testing -
- Summative Usability/Human Factors Validation -
- -Labeling
8. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application has the same intended use and fundamental technology as the predicate, Braun® Clear™ Hearing Aid BHA100 Series (K212609). In the same manner as its predicate, the Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application is a user-fitted wireless air-conduction hearing aid intended for over-the-counter use by individuals 18 years or older with perceived mild to moderate hearing impairment.
The same fundamental scientific technology is present in both hearing aids to allow the user to control and customize the device to the user's hearing needs. The subject device is essentially equivalent to the predicate in product design, dimension, use of Bluetooth technology and utilizing materials of high standard. The principles of operation of the subject device is explained as equivalent to the predicate. The subject device has no known biocompatibility issues, no known effect on the environment, or to other devices.
At a high level, the subject and predicate devices are based on the following technological elements:
- Self-fitting Air Conduction Hearing Aids -
- Home Healthcare Environment Use -
- -Wireless Application via Bluetooth
- On device controls -
- App (Lexie Application) -
- Software Platform Compatibility (iOS, Android) -
- Batteries (Replaceable, disposable, 1.45 Volt, Size 312, Zinc Air, Batteries) -
- Behind-The-Ear (BTE) -
- Bi-directional Microphones -
- User-Adjustable Wire -
- Different size ear tips -
- Feedback Cancellation -
- 16 Channel-wide Dynamic Input Compression -
- -Open and Closed Ear Tips in 3 sizes (Small, Medium, Large)
- 16 channel Noise Reduction -
The Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application includes:
- 16 Adjustable Frequency Bands -
- -Wind Noise Suppression
- Low Level Expansion, Adaptive and Fixed Microphone Directionality -
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- Wireless User Control Functions via Lexie App
Any differences between the subject and predicate device have been addressed through testing to a known performance standard or by showing equivalence in terms of functioning. These differences are not significant and do not change the effectiveness or safety of the subject device.
9. CLINICAL STUDIES
Study design:
The aim of this study was to compare the outcomes of the Lexie self-fitting strategy (SF) to the same hearing aid fitted by an audiologist (AF). This randomized controlled trial was conducted at the University of Pretoria, located in Gauteng, South Africa. In this study, the SF condition means that participants were provided with the Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application and were asked to set up and manage the devices using the Lexie app, entirely without professional support, as would be standard for this OTC model. Hearing aids were provided in their standard, consumer packaging, including all labeling and instructional material. Furthermore, they were fitted according to the proprietary fitting algorithm (Lexie Comfort) using the in-situ thresholds obtained via the Lexie app. The fitting algorithm is based on National Acoustics Laboratories' Non-Linear Version 2 (NAL-NL2), with additional adjustments aimed for a greater listening comfort. In the AF condition, participants were provided with the same Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application fitted to match the National Acoustics Laboratories' Non-Linear Version 2 (NAL-NL2) acoustic gain prescriptions as closely as possible. AF fitting was based on diagnostic audiometry conducted in a soundproof booth by the audiologist. Afterward, the participants in the AF group were orientated on the use and management of the hearing aid by the audiologist. Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application used in the study were identical to the device included for this submission.
The study was conducted as two phases (four visits per participant) of a randomized controlled trial (RCT).
Phase I was a two-week, take-home field trial after fitting the hearing aids. During the first 2weeks (mean duration = 16 days; SD = 5.8 days) no assistance or fine-tuning by the online Lexie hearing experts for the SF group was allowed, and no fine-tuning by the audiologist in the AF group. This procedure was followed to isolate and only compare the benefit provided by the fitting without the help of online support or adjustment.
Phase II commenced at the first follow-up appointment on the third clinical visit. During this appointment, participants of the AF group were allowed to request fine-tuning or assistance from the audiologist, if desired. The participants in the SF group were informed that assistance could be sought through the Lexie online hearing experts, if desired. Phase II was approximately 6 weeks in duration (mean duration = 40.4 days; SD = 15.9 days), and upon completion the final clinic visit and assessments were conducted. Figure 1 provides an overview of the study protocol. Blinding of the participants and researchers was not possible.
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Image /page/8/Figure/0 description: The image shows a diagram of a study with two phases. Phase I includes visits 1, 2, and 3, while Phase II includes visit 4. Visit 1 is the baseline evaluation, visit 2 is the hearing aid fitting, and visit 3 is the first follow-up. The mean field use for phase I is 16.1 days, while the mean field use for phase II is 40.4 days.
Figure 1. Trial timeline and design
The primary endpoint measure of this study was subjective benefit. This was conducted using the Abbreviated Profile of Hearing Aid Benefit (APHAB; primary endpoint variable) and the International Outcome Inventory of Hearing Aids (IOI-HA; secondary endpoint variable). Speech recognition in noise performance measured using the QuickSIN and digits-in-noise test (DIN) (secondary endpoint).
Participant Description
Table 1 below summarizes the participant characteristics for AF and SF groups, respectively. Overall, the analytical sample consisted of 64 participants between the ages of 30 and 84 years (mean = 63.6 years; SD = 14.1 years). Thirty-one were female, with a balanced gender distribution between the two groups. Eighteen participants (27%) had previous experience with a hearing aid, the time of experience ranging between two weeks and 12 years. The self-perceived degree of hearing loss (proportions of 'I have a little trouble' and 'I have a lot of trouble') was evenly distributed between the two groups. The distribution of pure tone airconduction audiometry results (conventional, reference audiometric thresholds), between 0.5 and 6 kHz, are presented in Figure 2. There was no significant difference in age (U = 440, z = -1.34, p = .18), or four frequency pure tone average (PTA 0.5 to 4 kHz), (U = 442, z = -1.3, p = .18) between the two groups.
| AF Group | SF Group | |
|---|---|---|
| Sample size- total | 32 | 32 |
| Gender | ||
| Male (n) | 18 | 15 |
| Female (n) | 14 | 17 |
| Age | ||
| Mean (SD) | 65.3 (14.9) | 62.0 (13.1) |
| Median (IQR) | 67 (18) | 63 (20) |
| Race | ||
| White (n) | 22 | 27 |
| Black (n) | 1 | 2 |
| Asian (n) | 9 | 2 |
| Other (n) | 0 | 1 |
| HA experience | ||
| New HA users (n) | 26 | 21 |
| Experienced HA users (n) | 6 | 10 |
| Self-perceived hearing loss | ||
| I have a little trouble (n) | 20 | 20 |
| I have a lot of trouble (n) | 12 | 12 |
| AF = Audiologist fit; SF= self-fit |
Table. Summary characteristics of the AF and SF participants
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Image /page/9/Figure/0 description: The image contains three plots, labeled A, B, and C, each displaying threshold values in dB HL against frequency in kHz. Plot A shows two lines representing groups AB and SF, with error bars indicating variability. Plots B and C show the median, minimum, maximum, 25th percentile, and 75th percentile thresholds across different frequencies. The threshold values generally decrease as frequency increases in all three plots.
Figure 2. Distribution of conventional pure tone audiometric frequencies combined left and right. (A) Distribution of pure tone thresholds for AF group, (B) Distribution of pure tone thresholds for the SF group. SF= self-fit; AF = audiologist fit, (C) Mean thresholds at 0.5 to 6 kHz, with error bars as standard deviation for the SF and AF groups.
Study Procedures
Visit 1: Baseline assessment
All participants received a standard audiometric evaluation, ensuring that participants met the inclusion criteria set out in the study protocol. This included otoscopy and pure tone airand bone-conduction audiometry performed by the audiologist. Participants also completed an in-situ hearing test conducted via the Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application, connected to the Lexie app in the soundproof booth. This was done by the participants independently.
Results of a separate clinical validation study confirmed the accuracy of the Lumen in-situ hearing check on a sample of 45 participants (90) ears, with varying levels of sensorineural hearing loss between 10 to 75 dB HL. In this study, the mean absolute difference (MAD) between the in-situ hearing test performed independently and the audiologist-performed audiometry varied between 5.8 to 8.1 across 0.5 to 6 kHz (Figure 3). This difference fell within a clinically accepted range of 10 dB HL.
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Image /page/10/Figure/0 description: The image contains two boxplots, labeled A and B, comparing "Reference" and "In-Situ" conditions. Plot A shows the PTA (dB HL) for both conditions, with similar median values around 40 dB HL. Plot B displays the threshold (dB HL) across different frequencies (0.5, 1, 2, 3, 4, and 6 kHz) for both conditions, with thresholds generally increasing with frequency and some outliers present.
Figure 3. Measured reference versus in-situ audiometry. (A) Reference versus in-situ PTA(0.5 to 4 kHz), (B) Reference versus in-situ thresholds across 0.5 to 6 kHz
Baseline unaided QuickSIN and Digits-in-Noise (DIN) tests were performed. The QuickSIN was developed as a shortened version of the Speech-in-Noise Test (SIN™) 3, to measure an SNR loss of hearing. In addition to the QuickSIN, speech-in-noise performance was measured using the South African English Digits-in-Noise test (DIN). The Abbreviated Profile of Hearing Aid Benefit (APHAB) was conducted to measure unaided subjective hearing difficulties. T
Visit 2: Hearing-aid fitting
After the clinical research audiologists established candidacy and conducted all baseline measures during Visit 1, participants were booked for Visit 2 for hearing aid fitting. During Visit 2, before fitting, participants were randomly allocated to the SF or AF group using a randomization app.
AF group
The audiologist assisted participants in downloading the Lexie app and signing into their precreated Lexie profile. The app functionality for the AF group was limited to volume and program controls and without access to the step-by-step onboarding tasks, online hearing experts, or the option to conduct the in-situ test via the app, which was provided to the SF participants. Real-ear measurements were conducted to fit the hearing aids to match the NAL-NL2 prescriptive target within a 5dB tolerance limit.
SF group
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Participants in the SF group were provided with the Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application in their standard packaging. Participants were then asked to set up the hearing aids through the app or by following the instructions in the user manual. The set-up included the online onboarding tasks, which are text and animated illustrations explaining how to set up and manage the hearing aids as well as an in-situ measurement procedure. The researchers provided no assistance in setting up or managing the hearing aids.
Visit 3: First follow up
After approximately 2 weeks (mean = 16 days; SD = 5.8 days; Figure 2) participants returned for a first follow-up assessment. Aided APHAB was completed along with the International Outcome Inventory for Hearing Aids (IOI-HA). Furthermore, participants completed an aided QuickSIN and DIN test.
After conducting the aided assessment, participants in the AF group were allowed to request fine-tuning or re-orientation by an audiologist, if desired. Participants in the SF group were informed that they could solicit help online by contacting the Lexie call-center. Call-center adjustments included any further hearing aid support by means of remote fine-tuning of the hearing aids, counseling, information, and troubleshooting. Then the participants were sent home, which marked the commencement of Phase II study.
Visit 4: Final Review
After approximately 6 weeks (mean = 40.4 days; SD = 15.9 days; Figure 2) participants returned for their final hearing aid review. Aided APHAB and IOI-HA were completed, and then subsequently proceeded with the aided QuickSIN and DIN. Participants in the SF group were asked whether they contacted the Lexie call center. However, the Lexie product experts also recorded all instances when participants requested assistance (capturing the nature of the problem as well as steps taken to remediate the issue). All SF participants could contact the Lexie call-center anytime between Visit 3 and 4.
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Study results
Primary endpoint analysis:
There were no significant differences for unaided baseline scores between the two groups on any subscale or global score. When re-evaluating after a two-week follow-up field trial, the participants in the SF group had less difficulty in background noise (p < .05) compared to the AF group. At six-weeks, independent samples t-test showed no significant differences between SF and AF groups for any of the APHAB (unaided, aided and benefit) scores (Figure 3). The aided and benefit scores fell within the 16.3 acceptance criteria for equivalence at the end of the trial.
Image /page/12/Figure/3 description: The image contains two violin plots, labeled A and B, comparing APHAB global benefit at week 2 and week 6, respectively. Each plot shows the distribution of APHAB global benefit for two groups, AF and SF. The y-axis represents the APHAB global benefit, ranging from -50 to 100. The data points are overlaid on the violin plots, providing a visual representation of the distribution and individual data points for each group.
Figure 3. Violin plot with boxplot indicating the distribution of APHAB global benefit scores for the AF and SF group (Positive scores indicate greater benefit). (A) APHAB global benefit scores between AF and SF group at the end of the 2-week trial and (B) APHAB global benefit scores between AF and SF group at the end of the 6-week trial. Violin plots show kernel probability density of thresholds, boxes are interquartile range (with median), and whiskers are 1.5 times the interquartile range. The points show the individual data for each participant in the AF and SF group. AF indicates audiologist-fit, SF= self-fit.
Secondary endpoint IOI-HA outcomes:
The IOI-HA was used at the two-week and 6-week field trial points (Figure 4). After the 2week field trial, participants in the SF group reported a significantly longer duration of hearing aid use per day (p < .05). Based on the total score (analyzed using non-parametric statistics as the variables were not normally distributed), there was a significant difference between the two groups, (p < . 05). However, when re-evaluating at the end of the 6-week trial, the differences between the groups were not significant for any of the subscales or total score (p > .05). All the subscales, at two and six-weeks were within the 1-point margin (ordinal scales) of the acceptance criteria. Furthermore, total scores at two and six-weeks fell within the 5point marqin of acceptance criteria.
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Image /page/13/Figure/0 description: The image contains four plots comparing two groups, AF and SF, across different IOI-HA scales at 2 weeks and 6 weeks. Plots A and B are bar charts showing the mean scores for each IOI-HA scale, with error bars indicating variability. Plots C and D are violin plots displaying the distribution of total scores for each group at 2 weeks and 6 weeks, respectively, with individual data points overlaid.
Figure 4. IOI-HA scores at 2 and 6 weeks for AF and SF groups. (A) Mean IOI-HA scores at 2 weeks across all scales for AF and SF participants (Larger scores indicate larger benefit). Error bars represent 1 SD from the mean. (B) Mean IOI-HA scores at 6 weeks across all scales for AF and SF participants. Error bars represent 1 SD from the mean, (C)Violin plot for the IOI-HA total score for AF and SF groups at 2 weeks showing kernel probability density. Boxes are interquartile range with median, and whiskers are 1.5 times the interquartile range. (D) Violin plot for the IOI-HA total score for AF and SF groups at 6 weeks showing kernel probability density. Boxes are interquartile range with median, and whiskers are 1.5 times the interquartile range.
Secondary endpoint speech-in-noise outcomes:
At baseline, before hearing aid fitting, there was no significant difference between the groups for either test (p > .05). At the end of the 2-week trial, the DIN aided scores were significantly poorer for the AF group than for the SF (p < .05), however, within the 1.8 dB SNR acceptance criteria. However, benefit scores were not significantly different between groups for either the QuickSIN or DIN test. When re-evaluated at the end of the 6-week trial, the differences were not significant for either aided QuickSIN or DIN tests (p > .05), or the calculated benefit scores.
Effectiveness:
Primary endpoint APHAB outcome: As a primary outcome measure, the SF group was equivalent compared to the AF group at 2-weeks and 6-week post fitting, falling within the marginal acceptance criteria for the APHAB specified for the study.
Secondary endpoint IOI-HA outcomes: The SF group was equivalent compared to the AF group at 2-weeks and 6-weeks post fitting, falling within the marginal acceptance criteria for the IOI-HA specified for the study.
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Secondary endpoint speech-in-noise outcomes: The QuickSIN and DIN demonstrated equivalent benefit for the SF compared to AF groups at 2- and 6-weeks post fitting, falling within the marginal acceptance criteria outlined for the study.
The methodology and design of this study was in line with the clinical evaluation of the predicate device BHA 100 Series Braun® Clear™ (subjective and objective performance outcomes) reported in the 510(k) Summary for K212609. The results demonstrate that the Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application were non-inferior to fitting by an audiologist using best-practice fitting algorithms. Effectiveness is equivalent to the predicate device (BHA 100 Series Braun® Clear™), which was similarly demonstrated to be equivalent to subjective and objective performance outcomes.
Safety:
The primary endpoint of safety for this clinical study was the occurrence of Adverse Events (AE) and Serious Adverse Events (SAEs). During the course of the study, there was one participant who withdrew from participation two days following hearing aid fitting. The participant developed a middle ear infection, a contraindication for using the Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application. A follow-up inquiry by the researcher showed that the event was unrelated to the use of the hearing aid. There were no SAEs occurring for any participant throughout the study. The safety endpoint of the clinical validation study was met. There was only one recorded AE. and after examination, was found to be unrelated to the use of the device. No SAEs were encountered by any of the participants. The Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application, therefore, were consistent with the safety profile of the predicate device (BHA 100 Series Braun® Clear™).
a. Human Factor Testing
A summative usability / human factors validation test of the Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application was conducted in accordance with the following:
- IEC 60601-1-6:2013 Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- -FDA Guidance - Applying Human Factors and Usability Engineering to Medical Devices, Guidance for Industry and Food and Drug Administration Staff (2016)
This summative human factors evaluation aimed to assess the usability of the Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application connected to the Lexie smartphone application (app) when the setup was self-directed by the user. Twenty-nine adult participants were observed during a simulated-use session which assessed the effectiveness and accuracy of the tasks required to set up the hearing aids via the app. Additionally, users' perceptions regarding usability and safety were obtained using a semistructured interview. The study results indicate that the Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application connected to the hearing aid app are usable, as evident by the high success rate (> 79%) on all use-related critical tasks. Two tasks were perceived as challenging while setting up the hearing aids via the app, namely (1) measuring the slim tubes and (2) inserting the hearing aids, indicating an opportunity for improvement in instruction to participants. Even so, only one participant selected the incorrect slim tube size and domes, the implication of which is minimal since it does not pose a risk to safety. Overall, participants displayed a high level of satisfaction when using the hearing aids and app, the majority (65.5%) noting that the hearing aids are "easy to
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use" and "user-friendly". The evaluation showed the Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application to be safe and effective for intended users and useenvironments.
10. NON-CLINICAL PERFORMANCE TESTING:
Non-clinical performance testing was conducted on the Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application to provide a reasonable assurance of safety and effectiveness as compared to the predicate device, Braun® Clear™ Hearing Aid BHA100 Series (K212609) and to provide support of substantial equivalence determination to the predicate device. The results are summarized in the table below:
| Test Standard/Method | Test Purpose | Result |
|---|---|---|
| IEC 60601-1:2005+A1:2012Medical electrical equipment - Part 1: General requirements for basicsafety and essential performance | Basic Safety andEssential Performance | Pass |
| IEC 60601-1-11:2015*Medical electrical equipment - Part 1-11: General requirements forbasic safety and essential performance - Collateral Standard:Requirements for medical electrical systems used in the homehealthcare environment | Basic Safety andEssential Performance | Pass |
| IEC 60601-2-66:2019Medical electrical equipment - Part 2-66: Particular requirements forthe basic safety and essential performance of hearing instrumentsand hearing instrument systems | Basic Safety andEssential Performance | Pass |
| IEC 60601-1-2:2014Medical electrical equipment - Part 1-2: General requirements forbasic safety and essential performance - Collateral Standard:Electromagnetic disturbances - Requirements and tests | ElectromagneticCompatibility | Pass |
| IEC 60118-13:2019Electroacoustics - Hearing aids - Part 13: Electromagneticcompatibility | ElectromagneticCompatibility | Pass |
| ANSI/ASA S3.22:2014 - Specification of Hearing Aid Characteristics | Acoustic Performance | Pass |
| ANSI CTA 2051:2017 - Personal Sound Amplification PerformanceCriteria | Acoustic Performance | Pass |
| ANSI ASA S3.6:2018 - Specification for Audiometers | Audiometric Performance | Pass |
| IEC 62304:2006+A1:2015 - Medical device software - SoftwarelifecycleprocessesFDA GuidanceFDA-2020-D-0957 - Guidance for the Content ofPremarket Submissions for Software Contained in Medical Devices,Guidance for Industry and Food and Drug Administration Staff - May11, 2005 | Software Verification andValidation | Pass |
| ISO 10993-1:2009/TC 1 2010 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process. | Biocompatibility | Pass |
| ISO 10993-5:2009 - Biological evaluation of medical devices - Part 5:Tests for in vitro cytotoxicity.ISO 10993-10:2010 - Biological evaluation of medical devices – Part10:Tests for irritation and skin sensitizationISO 10993-12:2021 - Biological Evaluation of Medical Devices – Part12: Sample Preparation and Reference MaterialsFDA Guidance FDA-2013-D-0350- Use of International Standard ISO10993-1, "Biological evaluation of medical devices -- Part 1:Evaluationand testing within a risk management process" - September 4, 2020 | ||
| IEC 60601-1-6:2010+A1:2013 - Medical electrical equipment - Part 1-6:General requirements for basic safety and essential performance -Collateral standard: UsabilityFDA Guidance FDA-2011-D-0469 - Applying Human Factors andUsability Engineering to Medical Devices, Guidance for Industry andFood and Drug Administration Staff - February 3, 2016 | UsabilityEngineering/HumanFactors Validation | Pass |
| FDA Guidance FDA-2018-D-3443 - Content of PremarketSubmissionsfor Management of Cybersecurity in Medical Devices, Guidance forIndustry and Food and Drug Administration Staff - October 18, 2018FDA Guidance FDA-2015-D-5105 - Post market Management ofCybersecurity in Medical Devices, Guidance for Industry and FoodandDrug Administration Staff - December 28, 2016 | CybersecurityCompliance | Pass |
| IEEE / ANSI C63.27:2017 - Evaluation of Wireless CoexistenceAAMI TIR 69:2020 - Risk Management of Radio-Frequency WirelessCoexistence for Medical Devices and Systems | Bluetooth SIGCompliance | Pass |
| ANSI C63.19:2019 - Methods of Measurement of CompatibilityBetweenWireless Communications Devices and Hearing Aids | Radio FrequencyImmunity | Pass |
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*Applicable sections
Note: Full Non-clinical Performance Testing results, including acceptance criteria and testing performance are reported in the 510(k) submission.
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ANSI ASA S3.22:2014 Measurements:
In order to demonstrate substantial equivalence with the predicate device, the Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application was evaluated per ANSI ASA S3.22 for acoustic performance. These results are summarized below:
| Test | Predicate Device:BHA100 Series Braun®Clear™ hearing aid | Subject Device:Lexie Lumen Self-FittingOTC Hearing Aid(s) withLexie Application | Discussion |
|---|---|---|---|
| OSPL90 Curve | Comparable to Predicate.Performance data supportsubstantial equivalence. | ||
| Max OSPL90 | Max <120dB SPLMeasured 114.4dB SPL | <120dB SPLMeasured result 114.4dB SPL | Equivalent to PredicateThe Lexie Lumen Self-Fitting OTC Hearing Aid(s)with Lexie Applicationmeets the OTC guidelinesfor input-controlledcompression and a useradjustable volume controlthat should not exceed anoutput limit of 117dB SPLat any frequency. |
| High FrequencyAverageOSPL90 (HFA-OSPL90) | 111 ± 2dB SPL | 110dB SPL | Comparable to Predicate.Performance data supportsubstantial equivalence |
| High FrequencyAverage Full-onGain (HFA-FOG) | 40 ± 2dB | 45dB | Comparable to Predicate.Performance data supportsubstantial equivalence |
| Reference TestGain (RTG) | 34 ± 4dB | 34dB | Equivalent to Predicate |
| FrequencyResponse | 200Hz to 8000Hz | 200Hz to 7000Hz | Comparable to Predicate.Performance data supportsubstantial equivalenceThe Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Applicationmeets the OTC guidelines for frequency responsewhere the lower cutofffrequency shall extend to |
| upper cutoff frequencyshall extend to 5kHz orgreater. | |||
| HarmonicDistortion | 500 Hz ≤ 1.5%800 Hz ≤ 2.0%1600 Hz ≤ 3.0% | < 5%THD@ 500Hz: 0.4%THD@ 800Hz: 0.2%THD@ 1600Hz: 0.4% | Comparable to Predicate.Performance data supportsubstantial equivalenceThe Lexie Lumen Self-Fitting OTC Hearing Aid(s)with Lexie Applicationmeets the OTC guidelinesfor harmonic distortion,where the total harmonicdistortion plus noise shallnot exceed 5 percent foroutput levels within one ofthe following sets of levels,depending on the testmethod. |
| EIN | <29 dB SPL | <32dB SPLActual measured value26.4dB SPL | Comparable to PredicateThe Lexie Lumen Self-Fitting OTC Hearing Aid(s)with Lexie Applicationmeets the OTC guidelinesfor self-generated noiselevels where self-generated noise shall notexceed 32 dB SPL.Performance data supportsubstantial equivalence |
| Latency | <15ms | <15ms | Equivalent to the predicateThe Lexie Lumen Self-Fitting OTC Hearing Aid(s)with Lexie Applicationmeets the OTC guidelinesfor latency, where latencyshall not exceed 15ms. |
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Based on the above information, the Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application, and our chosen predicate, BHA100 Series Braun® Clear™ hearing aid (K212609).
11. SUBSTANTIAL EQUIVALENCE
The Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application has the same intended use and as the predicate device, the BHA100 Series Braun® Clear™ hearing aid (K212609). Like the predicate device, the Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application is a user-fitted, wireless, air-conduction hearing aid, intended for over-thecounter use by individuals 18 years or older with perceived mild to moderate hearing impairment. Clinical data shows that the effectiveness of the Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application was non-inferior to fitting by a licensed audiologist with a calibrated clinical audiometer for both self-fitting hearing assessment/ Furthermore, human
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factor testing displayed a high level of user satisfaction and is therefore substantially equivalent to the predicate device in acoustic performance, usability , and safety. Non-clinical performance testing has been conducted to ensure that the device does not raise any questions of safety and effectiveness as established by the predicate device. Device and application firmware and software have been validated per the same standards as used to validate the device and application firmware and software of the predicate device. Lastly, design verification results demonstrate that the subject device has substantially equivalent performance to the predicate device.
12. Summary - Conclusion
The special controls for self-fitting hearing aids as per 21 CFR 874.3325, are met in the following aspects; the clinical data has evaluated the effectiveness of the self-fitting strategy, the electroacoustics parameters (including max output limits, distortion levels, self-generated noise levels, latency, and frequency response) was specified and tested, performance data demonstrates the EMC, electrical and thermal safety of the software verification, validation, and hazard analysis has been performed. The wireless technology performance testing has validated safety of exposure to non-ionizing radiation of wireless technology functions. The usability testing has demonstrated that users can correctly use the device as intended under anticipated conditions of use.
In conclusion the evidence provided proves that the outcomes of the Lexie self-fit model (with Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application) are equivalent to an audiologist's best-practice model. Furthermore, by definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Based on the comparison and analysis above, the Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application is determined to be substantially equivalent to the predicate device (BHA 100 Series Braun® Clear™).
§ 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.