(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). 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: |
§ 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.