Search Results

This air conduction hearing instrument is intended to amplify sound pressure waves and transmit the signal to the external ear through the medium of air to compensate for hearing losses of mild to moderate degree.

Indications for use include persons with mild to moderate hearing impairment depending upon specific characteristics of the hearing loss and the patient's environmental situations.

The indication for use of the air conduction hearing aids in this file indication is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies):
Severity: Slight, Mild, Moderate
Configuration: High Frequency - Precipitously Sloping, Gradually Sloping, Reverse Slope, Flat
Other: Low tolerance

The SONIC innovations Completely-in-the-Canal DSP Hearing Aid with Soft Shell is a programmable hearing aid with fully digital signal processing and full dynamic range multiband compression (multiplicative DSPTM) that allows independent adjustment of gain and compression characteristics within each frequency band from 250 to 8000 Hz. The SONIC innovations hearing aid provides database storage of patient information and hearing aid fitting parameters.

Assembled from standard hearing aid components mounted with custom microchips. The hearing aid soft shell is manufactured from biocompatible materials that have been used in other medical devices.

The Soft Shell is removable and/or replaceable, and can be cleared or replaced as needed. The shells are offered in a few basic sizes and selected by the hearing aid dispenser.

Except for the Soft Shell, 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.

Two versions of the Soft Shell are available, both made of biocompatible materials. The two versions of the shell are available in multiple sizes, the specific one being selected by the hearing aid dispenser as suitable for an individual patient.

The Soft Shell may be cleaned and/or replaced as needed by either the hearing aid dispenser or the individual patient.

The provided text for the Sonic Innovations CIC DSP Hearing Aid (K984518) does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

The document is a 510(k) Premarket Notification summary that:

• Identifies the device.
• States its intended use and indications for use.
• Claims substantial equivalence to previously marketed devices.
• Lists technical characteristics in accordance with ANSI S3.22 1987.
• Describes the materials and features.

Crucially, it does not include any performance data, clinical trial results, or details of studies conducted to evaluate the device against specific performance benchmarks. The statement "Technical specifications are in accordance with ANSI S3.22 1987" implies compliance with a standard, but it doesn't provide the measured performance against that standard.

Therefore, I cannot fulfill your request for the tables and study details because the necessary information is not present in the provided text.

Ask a specific question about this device