(59 days)
Mild to severe conductive, mixed or sensoryneural hearing loss
Mild to severe conductive, mixed or sensoryneural hearing loss when cosmetics are of some concern
Mild to moderate conductive, mixed or sensoryneural hearing loss when cosmetics are of major concern, but the ear can not accommodate a complete in the canal style
Mild to moderate conductive, mixed or sensoryneural hearing loss when cosmetics are of major concern.
Mild to severe conductive, mixed or sensoryneural hearing loss when a more cosmetic AE is desired.
Mild to severe conductive, mixed or sensoryneural hearing loss when cosmetics are a major concern but the ear prevents use of a CIC or MM.
Normal low and middle frequency hearing with a sloping mild to moderate high frequency sensory neural or mixed loss.
To amplify and transmit sound to the ear.
DSD K-amp or Intrigue programmable circuitry
Assembled from standard components that are widely used by other hearing aid manufacturers.
"Technical specifications comply with S3.2-1987 ANSI Standards"
Frequency response dictated by individual audiogram
Volume control similar to other devices.
Standard size 13 battery
Standard size 312 battery
Standard size 10A battery
Standard size 10a or 5a battery
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment for the Auris hearing aids. The documents describe different models of Auris hearing aids, their intended use, features, technical characteristics, and the FDA's 510(k) clearance approval, but they do not include any specific clinical study data or performance metrics against defined acceptance criteria.
§ 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.