(15 days)
To amplify and transmit sound to the ear.
Dahlberg Hearing Aid with multi-channel compression circuit
This document (K964530) is a 510(k) summary for a Dahlberg Hearing Aid and does not contain detailed information about acceptance criteria or a specific study proving the device meets those criteria in the context of an AI/ML medical device.
The provided text describes a traditional medical device (a hearing aid) and its substantial equivalence to a previously cleared device. It outlines general technical characteristics, intended use, and materials. It explicitly states: "Dahlberg utilizes the ANSI S3.22-1987 methodology to test and obtain performance data for hearing aids." This suggests that the acceptance criteria for this device would be adherence to the ANSI S3.22-1987 standard for hearing aid performance, and the study that proves this would be the testing conducted according to that standard.
However, the specific metrics, thresholds, and details of such a study (sample size, data provenance, ground truth, etc.) are not present in this 510(k) summary. The questions you've asked are typically relevant to the validation of AI/ML-driven medical devices, which this product is not.
Therefore, I cannot populate the table or answer the specific questions based on the provided input. The input describes a traditional medical device, not an AI/ML system.
§ 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.