DevicePMAs@therightstef:P970051_S010 JSONTXT 11 Projects

Approval for a design modification including the straight electrode of the ci 24 m with the 24 k downsized stimulator receiver. The device, as modified, will be marketed under the trade name ci 24r(st), and is indicated for children age 18 months through 17 years of age who have bilateral profound sensorineural deafness and demonstrate little or no benefit from appropriate binaural hearing aids, and for adults, age 18 years and older who have bilateral moderate to profound sensorineural hearing loss and obtain limited benefit from appropriate hearing aids.