ADVANCED BIONICS CI-5826 (02) PDF Document

To connect the ADVANCED BIONICS CI-5826 M Programming Cable:

1. Plug the micro-HDMI end of the programming cable into the CPI-3.

2. Slide the Naída CI M or Sky CI M sound processor onto the connector of the programming cable.

3. Verify that the sound processor appears in the Target CI fitting software.

To remove the sound processor, slide the Naída CI M or Sky CI M sound processor off of the connector of the programming cable.

The ADVANCED BIONICS CI-5826 M Programming Cable should be kept free from dirt and dust. Clean and dry it thoroughly after any exposure to dust, dirt, fluids, or high humidity. Clean the contacts as needed using a dry cotton swab. Do not immerse the M Programming Cable in liquid.

• The programming cable must only be used by trained/qualified professionals.

• Instruct patients to remove the headpiece if they encounter any overly loud sound or discomfort during fitting.

• Do not attempt to service or modify the Naída CI M, Sky CI M, or its accessories. Doing so may compromise system performance and will void the manufacturer’s warranty. Products should be serviced only at Advanced Bionics and damaged products should be returned to Advanced Bionics.

Undesirable side effects of the Naída CI M or Sky CI M system may include skin irritation and discomfort from pressure on the ear, device overheating, or overly loud sounds.

The ADVANCED BIONICS CI-5826 is an external component of the HiResolution Bionic Ear System, which is intended to restore a level of auditory sensation to individuals with severe-to-profound sensorineural hearing loss via electrical stimulation of the auditory nerve.

Adults

• 18 years of age or older.

• Severe-to-profound bilateral sensorineural hearing loss or severe-to-profound unilateral hearing loss.

• Post-lingual onset of severe or profound hearing loss.

• Limited benefit from appropriately fitted hearing aids, defined as scoring 50% or less on a test of open-set sentence recognition (HINT Sentences).

Children

• 12 months through 17 years of age.

• Severe-to-profound bilateral sensorineural deafness or severe-to-profound unilateral hearing loss.

• Use of appropriately fitted hearing aids for at least 6 months in children 2 through 17 years of age, or at least 3 months in children 12 through 23 months of age. The minimum duration of hearing aid use is waived if x-rays indicate ossification of the cochlea.

• Little or no benefit from appropriately fitted hearing aids. In younger children (< 4 years of age), lack of benefit is defined as a failure to reach developmentally appropriate auditory milestones (such as spontaneous response to name in quiet or to environmental sounds) measured using the Infant-Toddler Meaningful Auditory Integration Scale or Meaningful Auditory Integration Scale or ≤ 20% correct on a simple open-set word recognition test (Multisyllabic Lexical Neighborhood Test) administered using monitored live voice (70 dB SPL). In older children (≥ 4 years of age), lack of hearing aid benefit is defined as scoring ≤ 12% on a difficult open-set word recognition test (Phonetically Balanced-Kindergarten Test) or ≤ 30% on an open-set sentence test (Hearing In Noise Test for Children) administered using recorded materials in the sound field (70 dB SPL).

The intended users of the ADVANCED BIONICS CI-5826 M Programming Cable are hearing care professionals fitting the Naída CI M or Sky CI M Sound Processors. The hearing care professional should be trained in the use and fitting of the cochlear implant system.

The intended use environments of the M Programming Cable are healthcare environments. It is not worn by the recipient and there is no minimum or maximum limit on the time that it can be used.

The Naída CI M Programming Cable is compatible with Naída CI M and Sky CI M Sound Processors and the CPI-3 from Advanced Bionics.

The expected life of the M Programming Cable is 3 years.

Dispose of the M Programming Cable in accordance with applicable national and local regulations. Hazardous materials are not applicable to this product.