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The hearing aid is intended to be used to amplify and transmit sound to the ear and thereby compensate for impaired hearing. The hearing aid is a disposable, extended-wear air conduction hearing aid, designed to be used and worn by hearing-impaired persons. Hearing assistance is achieved through amplification of sound pressure waves, which are transmitted to the external ear canal via air conduction. The hearing aid is initially placed in the ear canal by an appropriately trained ENT physician, Audiologist or Hearing Aid Dispenser and can remain in the ear canal for up to 4 months or until the battery is depleted. It is then replaced by a new device by the previously mentioned parties, or by an adult patient 22 years and older who have been wearing Lyric for a minimum period of 3 months under the direction and training of the ENT physician, Audiologist or Hearing Aid Dispenser. Upon device removal the hearing aid is discarded.

Lyric4 is a non-sterile, extended wear hearing aid that is worn 24 hours a day, 7 days a week for months-at-a-time. Due to the deep placement inside the ear canal, it is 100% invisible. For patients, Lyric4 is very easy to operate with no batteries to change, no ongoing maintenance required and no daily insertion or removal. Lyric4 takes advantage of the deep placement in the ear canal for natural sound quality and the natural directivity of the pinna. Lyric4 is designed for single insertion and is not reused once removed from the ear (single-use only). Compared to the currently marketed Lyric4, there are no modifications to the technology (hardware and software), materials, or accessories when Lyric4 is used for self-replacement. Only the indications for use statement and labeling have been modified.

The Lyric 2 hearing aid is a disposable, extended-wear air conduction hearing aid, designed to be used and worn by hearing-impaired persons. Hearing assistance is achieved through amplification of sound pressure waves, which are transmitted to the external ear canal via air conduction. The hearing aid is placed in the ear canal by an appropriately trained ENT Physician, Audiologist or Hearing Aid Dispenser and can remain in the ear canal for up to 4 months or until the battery is depleted. Upon device removal the hearing aid is discarded.

Lyric2 is a disposable, programmable, deep-canal, extended-wear, air conduction hearing device, It uses an analog, digitally programmable WDRC ("Wide Dynamic Range Compression") circuit with very low power consumption. Hearing assistance is achieved through amplification of sound pressure waves, which are transmitted to the external ear canal via air conduction. The amplification characteristics are contained in digitally programmable memory, and adjustment of device parameters is achieved through the proprietary Fitting System and Software. The Lyric2 consists of: - A programmable application specific integrated circuit ("ASIC") for analog signal processing. . An analog microphone receives sound waves that will be amplified and transmitted to the speaker. - A custom made built-in battery to power the amplification circuit. . - A magnetic sensor to program device parameters and to remotely control user settings (On/Off/Sleep/Volume). - Mechanical components to protect the device from cerumen. . - A removal loop to allow the user and/or professional to remove the device. . - . Seals that allow the device to fit comfortably in the ear canal Accessories available for Lyric2: - User Remote Control - . Device sizer to determine best device size - Length sizer to determine insertion depth . - . An insertion tool for insertion and removal of device and device sizers - A dedicated software and programming interface to program the device with customer · ● specific settings

The Lyric Hearing Aid is a disposable, extended-wear, air conduction hearing aid, designed to be used and worn by hearing-impaired persons. Hearing assistance is achieved through amplification of sound pressure waves, which are transmitted to the external ear canal via air conduction. The hearing aid is placed in the ear canal by an appropriately trained ENT Physician, Audiologist or Hearing Aid Dispenser and can remain in the ear canal for up to 4 months or until the battery is depleted. Upon device removal the hearing aid is discarded.

The Lyric Hearing Aid amplifies and delivers sounds via air conduction to the external ear of persons with hearing loss. The microphone transforms sound waves into electrical signals and delivers it to the hearing aid circuit, which is powered by the battery. The amplification characteristics are contained in digitally programmable memory and adjustment of device parameters is achieved through the proprietary HandFit™ Fitting System and Software.

The InSound XT Hearing Aid is a disposable, extendedwear, air conduction hearing aid, designed to be used and worn by hearingimpaired persons. Hearing assistance is achieved through amplification of sound pressure waves, which are transmitted to the external ear canal via air conduction. The hearing aid is placed in the ear canal by an ENT physician and it can remain in the ear canal for up to 4 months or until the battery is depleted. Upon device removal, the hearing aid is discarded.

The InSound XT Series Hearing Device amplifies and delivers sounds via air conduction to the external ear of persons with hearing loss. The microphone transforms sound waves into electrical signals and delivers it to the hearing aid circuit, which is powered by the battery. The hearing device is extendedwear (up to 4 months) and disposable. It is placed deep in the ear canal by an ENT physician. The amplification characteristics are contained in digitally programmable memory and adjustment of device parameters is achieved through the proprietary HandFit™ Fitting System and Software.

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.

A hearing Aid and/or Tinnitus Masker/Habituator. No hearing loss or a mild to severe high frequency hearing loss where the patient exhibits a low hearing loss where the patient's response to tinnitus is characterized by intolerance to specifically the inability to cope with head noises, anxiety, depression or the inability to function in daily life activities. When cosmetics are not an issue. A hearing Aid and/or Tinnitus Masker/Habituator. No hearing loss or a mild to severe high frequency hearing loss where the patient exhibits a low hearing loss when the patient's response to tinnitus is characterized by intolerance to specifically the inability to cope with head noises, anxiety, depression or the inability to function in daily life activities. When cosmetics are an issue. A hearing Aid and/or Tinnitus Masker/Habituator. No hearing loss or a mild to severe high frequency hearing loss where the patient exhibits a low hearing loss where the patient's response to tinnitus is characterized by intolerance to specifically the inability to cope with head noises, anxiety, depression or the inability to function in daily life activities. When cosmetics are a major issue.

Tranquil TRI-OE: I-T-E hearing aid and/or tinnitus masker/habituator with Class A Noise Generator, Class D Noise Generator, DSD K-amp programmable or Intrigue Programmable. Assembled from standard components. Technical specifications comply with S3 2-1987 ANSI Standards. Frequency response dictated by individual audiogram. Volume control mechanical or electronic. Standard Size 312 battery. Tranquel TRI-COE: I-T-C hearing aid and/or tinnitus masker/habituator with Class A Noise Generator, Class D Noise Generator, DSD K-amp programmable or Intrigue Programmable. Assembled from standard components. Technical specifications comply with S3 2-1987 ANSI Standards. Frequency response dictated by individual audiogram. Volume control mechanical or electronic. Standard Size 10A battery. Tranquel TRI-CIC: C-I-C hearing aid and/or tinnitus masker/habituator with Class A Noise Generator, Class D Noise Generator, DSD K-amp programmable or Intrigue Programmable. Assembled from standard components. Technical specifications comply with S3 2-1987 ANSI Standards. Frequency response dictated by individual audiogram. Volume control mechanical or electronic. Standard Size 10A battery.

A. General Indications: 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: 2. Mild X, 3. Moderate X, 4. Severe X. Configuration: 1. High Frequency - Precipitously Sloping X, 2. Gradually Sloping X, 4. Flat X, 5. Other: steeply sloping X. Other: 1. Low Tolerance to Loudness X.

Programmable OnQue for HS, CCA, and CAMEO Models

The Sonix Hearing Aid Fitting and Programming System is a lightweight hand-held batterypowered device intended for use in fitting and programming Sonix hearing aids using individual patient audiogram and/or loudness data. It also provides database storage of patient identification information, audiogram, loudness information and hearing aid selection and fitting parameters.

The Sonix Hearing Aid Fitting and Programming System is a hand-held, battery-powered, portable device used to fit and program Sonix hearing aids and to store certain patient data.

A. General Indications: The intended use of this model hearing aid is to amplify sound pressure waves and transmit the signal to the external ear, through the medium of air, to compensate for impaired hearing. This device is indicated for individuals with losses in the following categories: Severity: 1. Slight X 2. Mild X 3. Moderate X 4. Severe 5. Profound Configuration: 1. High Frequency - Precipitously Sloping X 2. Gradually Sloping 3. Reverse Slope X 4. Flat 5. Other Other: X 1. Low Tolerance To Loudness 2. 3.

OPUS 2 - CANAL SERIES ( ITC )