(292 days)
The Lumen® 155-SF self-fitting, wireless air conduction 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. The device is intended for over-the-counter sales without the assistance of a hearing health 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 Lumen 155-SF self-fitting hearing aid(s) with Sentibo application is a self-fitting wireless air conduction Behind-The-Ear (BTE) hearing aid consisting of the Intricon hardware and Sentibo software to be used on an Apple mobile device (mobile device not included) including wired lightning connector Apple EarPods for the assessment (not included) designed for a single user. The Sentibo app is available only on iOS. The Lumen 155-SF self-fitting OTC hearing aid(s) with Sentibo application is a behind the ear device that includes self-adjustable coupling by means of a slim tube and ear tip/open dome. The hearing aids can be fine-tuned by the user or remotely at the request of the user via the use of QR codes. Once the hearing aids are switched on, the software (Sentibo app) is required for the initial set-up, which is done via the smart phone and requires Apple EarPods with lightning connector to complete (not included). The Sentibo self-fitting software allows the consumer to self-select a hearing profile from a list of options by listening to digitized speech embedded in the software while scrolling through the hearing profiles in real-time through the Apple EarPods. After the setting is selected, the settings can be transferred from the smart phone to the hearing aid directly, though direct audio streaming from the smart phone to the hearing aid is unsupported with the Lumen 155-SF firmware. All Sentibo settings are stored in the application itself, and no internet service is required to perform the self-fitting. The Sentibo application provides 24 predefined options. At the conclusion of the assessment, the software will program hearing aids wirelessly and the user will wear the hearing aids per normal use. The smartphone app will function as a software accessory, allowing the user to make minor adjustments to the hearing aids. The hearing aid is intended to be used with the Sentibo App and to be worn and removed daily by the end user.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Tests | Reported Device Performance (Lumen 155-SF) | Predicate/Reference Performance | Discussion of Differences & Meeting Criteria |
|---|---|---|---|---|
| Intended Use | Amplifies sound for adults 18+ with perceived mild to moderate hearing impairment; user-adjusted; OTC sales without hearing health professional assistance. | Meets this exact indication. | Predicate (Nuheara IQbuds 2 PRO) and Reference (Bose SoundControl) have similar intended uses. | Lumen 155-SF's intended use is substantially equivalent to the predicate and reference devices. Minor wording changes in the intended use statement are considered redundant in context of a self-fitting hearing aid. |
| Electro-Acoustic Characteristics (ANSI/ASA S3.22 & ANSI/CTA 2051) | Latency ≤ 15 ms | 5.8 ms | Predicate: 5 ms; Reference: 5.5 ms | Meets criteria of being ≤ 15 ms. Within measurement uncertainty tolerance of predicate/reference. |
| Frequency Response |
§ 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.