(45 days)
This product is used by hearing aid users as an accessory to remove Inis product is about by nearing overnight while they sleep.
A hearing aid drying appliance is an accessory for use by hearing aid users to remove moisture that collects in the hearing aid during normal use. Various products, most using a desiccant, have been in use for many years. Dry & Store uses a desiccant, a fan, and heat all common technologies - to remove much of the moisture. Along with drying, the product features a sanitizing cycle using a 4-watt ultraviolet bulb, commonly in use for a number of applications outside the hearing aid accessory market.
The provided document is a 510(k) summary for the "Dry & Store Hearing aid drying appliance." This document focuses on establishing substantial equivalence to existing devices and does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
The 510(k) summary explicitly states:
"The manufacturer makes no claims as to degree of dryness, humidity level claimed after a drying cycle, or any other claim that suggests a minimum performance level."
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets those criteria from the provided text. The document is primarily concerned with regulatory clearance based on substantial equivalence, not performance validation against specific metrics.
§ 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.