Indications

Information on indications and suitability of cochlear implants for adults and children.

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Candidacy criteria for cochlear implants vary according to country and the relevant competent authority which monitors medical devices (e.g. TUV in the European Union, FDA in the US, TGA in Australia). Always consult your relevant authority for the specific cochlear implant candidacy criteria that apply in your country.

The indications and contraindications contained in the Nucleus® 5 cochlear implant physician’s package insert are reproduced below. The cochlear implant is intended to restore a level of auditory sensation via the electrical stimulation of the auditory nerve.

 

 

Nucleus cochlear implant diagram

Adults

The Cochlear™ Nucleus® CI422 cochlear implant with straight electrode is intended for use in individuals 18 years of age or older who have bilateral, pre, peri or postlinguistic sensorineural hearing impairment and obtain limited benefit from appropriate binaural hearing aids. These individuals typically have moderate to profound hearing loss in the low frequencies and profound (≥90 dB HL) hearing loss in the mid to high speech frequencies. Limited benefit from amplification is defined by test scores of 50% correct or less in the ear to be implanted (60% or less in the best-aided listening condition) on tape-recorded tests of open set sentence recognition.

Children

The cochlear implant system is intended for use in children 12 to 24 months of age who have bilateral profound sensorineural deafness and demonstrate limited benefit from appropriate binaural hearing aids. Children two years of age or older may demonstrate severe to profound hearing loss bilaterally. In younger children, limited benefit is defined as lack of progress in the development of simple auditory skills in conjunction with appropriate amplification and participation in intensive aural habilitation over a three to six month period. It is recommended that limited benefit be quantified on a measure such as the Meaningful Auditory Integration Scale or the Early Speech Perception test. In older children, limited benefit is defined as ≤ 30% correct on the open set Multisyllabic Lexical Neighbourhood Test (MLNT) or Lexical Neighbourhood Test (LNT), depending upon the child’s cognitive and linguistic skills. A three to six month hearing aid trial is recommended for children without previous aided experience.

Contraindications

A cochlear implant is not indicated for individuals who have the following conditions:

  1. deafness due to lesions of the acoustic nerve or central auditory pathway
  2. active middle ear infections
  3. absence of cochlear development
  4. tympanic membrane perforation in the presence of active middle ear disease.