(29 days)
The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)): Severity: 1. Slight X 4. Severe Configuration: ✓ 1. High Frequency - Precipitously Sloping
This air-conduction behind-the-ear hearing instrument, intended to amplify sound . pressure waves and transmit the signal to the external ear through the medium of air, is designed to compensate for hearing losses from mild to severe. The device is powered by a standard hearing aid battery (type 13). . The device is manufactured and delivered completely assembled to the hearing aid . dispenser using materials and techniques widely used by other manufacturers of hearing devices. The intended use, performance specifications, functions and operations of the . ReSound® Digital 2000-BT are essentially identical to that described in the 510(k) Premarket Notification for the ReSound® BT4 Personal Hearing System™ The predicate device has the ability to retain programs in memory, and, with the use of . the optional remote control, up to three programs are accessible. The ReSound® Digital 2000-BT, however, is remote control/programmer dependent, therefore, no programs are retained in the device if the device is turned off. The ReSound® Digital 2000-DP is programmed by the hearing health care professional with up to 4 different programs per ear via Noah based ReSound ReSource™ software. . The operation and functioning of the DAI option is identical to that offered by other hearing aid manufacturers.
The provided text does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding sample sizes, expert qualifications, or ground truth establishment.
Instead, the document is a 510(k) premarket notification letter from the FDA regarding the ReSound Digital 2000-BT hearing aid. It focuses on establishing substantial equivalence to a predicate device (ReSound BT4 Personal Hearing System™) based on design, intended use, performance specifications, and manufacturing.
Here's a breakdown of why the requested information isn't present:
- Acceptance Criteria and Reported Performance: The document outlines the functional similarities and differences between the new device and the predicate device, but it does not specify quantitative performance metrics or acceptance criteria for those metrics. For example, it mentions the device "is designed to compensate for hearing losses from mild to severe" but doesn't provide numerical thresholds for what constitutes "compensating."
- Study Details (Sample Size, Data Provenance, Experts, Adjudication): This type of detailed study information is typically found in clinical trial reports or performance evaluation summaries, which are not part of this 510(k) letter. The letter primarily focuses on regulatory approval based on equivalence.
- MRMC Comparative Effectiveness Study: There is no indication of a comparative effectiveness study involving human readers (or in this case, human users of hearing aids) with and without AI assistance.
- Standalone Performance: While the document describes the device's functionality, it doesn't present data from a standalone performance study in the way one might expect for an AI diagnostic device. The performance is implied to be similar to the predicate device.
- Ground Truth Type: For a hearing aid, "ground truth" would likely relate to objective measures of hearing improvement or speech intelligibility, but these are not detailed in this document.
- Training Set Sample Size and Ground Truth Establishment (for AI): Since this is a hearing aid and not an AI-driven diagnostic device in the modern sense (the "digital" refers to digital signal processing within the hearing aid, not a separate AI algorithm being trained on data), there's no mention of a training set or how ground truth for such a set would be established.
Summary based on the provided text:
The document focuses on demonstrating substantial equivalence to an existing predicate device rather than presenting a performance study with explicit acceptance criteria. Therefore, most of the requested information cannot be extracted from this text.
§ 874.3300 Air-conduction hearing aid.
(a)
Identification. An air-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. An air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. The air-conduction hearing aid generic type excludes the group hearing aid or group auditory trainer, master hearing aid, and the tinnitus masker, regulated under §§ 874.3320, 874.3330, and 874.3400, respectively.(b)
Classification. Class I (general controls). This device is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 874.9.