(63 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:
X 2. Mild
X 3. Moderate
X 4. Severe
Configuration:
X 1. High Frequency - Precipitously Sloping
X 2. Gradually Sloping
X 3. Reverse Slope
X 4. Flat
Other
X 1. Low tolerance To Loudness
This air-conduction in-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 type 13 hearing aid battery (type 312 for the half-shell . option).
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® ED4 . Personal Hearing System™ are essentially identical to that described in the 510(k) Premarket Notification for the ReSound® Personal Hearing System™ ED3.
The ability to program digitally the fitting parameters of the hearing device is the same as in . the ReSound® Personal Hearing System™ ED3, as is the ability to change the characteristics of the sound processing and adjust the volume via an ultrasound remote control.
The provided document is a 510(k) premarket notification for a hearing aid, the ReSound ED4 Personal Hearing System™. It asserts substantial equivalence to a predicate device, the ReSound Personal Hearing System ED3a.
This document does not contain acceptance criteria or a study that proves the device meets specific performance criteria. Instead, it asserts substantial equivalence to a previously cleared device (ReSound Personal Hearing System ED3a, K951379) based on the following justifications:
- Intended Use: The device is an air-conduction in-the-ear hearing instrument intended to amplify sound pressure waves and transmit the signal to the external ear through the medium of air, designed to compensate for hearing losses from mild to severe. This is essentially identical to the predicate device.
- Power Source: Powered by a standard type 13 hearing aid battery (type 312 for half-shell option).
- Manufacturing: Manufactured and delivered completely assembled using widely used materials and techniques.
- Performance Specifications/Functions: Intended use, performance specifications, functions, and operations are essentially identical to the predicate device.
- Programmability: Ability to program digitally the fitting parameters and adjust sound processing/volume via ultrasound remote control is the same as the predicate device.
Therefore, I cannot populate the requested table or answer the questions regarding acceptance criteria and a study design because this information is not present in the provided text.
The document focuses on the regulatory process of demonstrating substantial equivalence, which primarily relies on comparing the new device to a legally marketed predicate device, rather than presenting new performance study data against pre-defined acceptance criteria for the new device itself.
§ 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.