The Cochlear Corporation made a formal request for a national coverage determination (NCD) to conform to its more recent labeling for the Nucleus 24 Contour implant system. The Food and Drug Administration (FDA) expanded the indications for this product in November 2000. The request included the necessary changes to be made to CIM 65-14, the Nucleus 24 Contour cochlear implant’s system package insert, and supporting documentation.
The FDA labeling for this product for adults defines the population to be served by the device as those with test scores of 50 percent or less correct in the ear to be implanted (60 percent or less correct in best aided listening condition) on tape- recorded tests of open set sentence recognition. The Nucleus 24 Contour labeling also includes children 12 to 24 months of age who have bilateral profound sensorineural deafness and demonstrate limited benefit from appropriate binaural hearing aids. 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 3 to 6 month period.
Medicare currently has an NCD for cochlear implants in section 65-14 of the CIM. In addition to some general coverage restrictions, such as sensorineural hearing loss, freedom from infection, ability to undergo extended rehabilitation, etc., the policy for adults includes specific test scores. That is, adults must demonstrate test scores of 30 percent or less on sentence recognition scores from tape-recorded tests in the patient’s best listening condition. Cochlear implants in children are not covered until the child is 2 years old and then only where deafness is demonstrated by the ability to improve on age appropriate closed-set word identification tasks with amplification. This policy was based on previous FDA approved labeling.
We invite the public to submit medical evidence along with published scientific literature or comments regarding the expanded use of the cochlear implant, i.e., the use of the cochlear implant for the expanded indications for adults and children, patient selection criteria, and appropriate screening needed.