PMA P970051S172

Device

NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Applicant

Cochlear Americas

Product code

MCM

Decision date

2020-03-17

Generic name

Implant, cochlear

Approval order statement

Approval for the IFU for Nucleus 24 Cochlear Implant System: 1) The Nucleus 24 Cochlear Implant System is intended for 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.2) 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.3) The Nucleus 24 cochlear implant system is intended for use in children 9 to 24 months of age who have bilateral profound sensorineural deafness and demonstrate limited benefit from appropriate binaural hearing aids.4) Children two years of age or older may demonstrate severe to profound hearing loss bilaterally.5) 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.6) In older children, limited benefit is defined as <= 30% correct on the open set Multisyllabic Lexical Neighborhood Test (MLNT) or Lexical Neighborhood Test (LNT), depending upon the childs cognitive and linguistic skills. A three to six-month hearing aid trial is recommended for children without previous aided experience.