The Clarion Multi-Strategy Cochlear Implant--surgical technique, complications, and results: a single institutional experience.

OBJECTIVE

This study aimed to review a single institution's experience with Clarion Multi-Strategy Cochlear Implant with respect to surgical technique, surgical complications, and rehabilitative outcome.

STUDY DESIGN

This study was a review of patients implanted with the Clarion Multi-Strategy Cochlear Implant.

SETTING

The setting was a tertiary referral center with care delivered in the inpatient and outpatient environment.

PATIENTS

The first 37 patients were implanted under an Investigational Device Exemption as part of the Food and Drug Administration (FDA) clinical trial of the Clarion implant. Subsequent patients were implanted after the device received FDA approval. Patients met the following criteria for implantation: 18 years of age or older, psychological and emotional stability, profound postlingual deafness without evidence of middle ear disease, one cochlea at least partially patent, and marginal or no benefit from conventional hearing aids.

INTERVENTION

Patients received implantation with the Clarion Multi-Strategy Cochlear Implant.

MAIN OUTCOME MEASURES

Measured were presence or absence of surgical complications and auditory performance with open- and closed-set word and sentence recognition testing.

RESULTS

A total of 47 patients have been implanted. Three patients have suffered complications: two cases of delayed-onset facial palsy both resolved with steroid therapy and one case of internal cochlear stimulator migration required refixation. Significant improvement in speech understanding has been seen in the majority of patients who were implanted within the first 6 months of device use. Specifically, at 6 months, scores on CID (Central Institute for the Deaf) sentences (implant alone) improved from a preoperative mean of 9% to a mean of 72%, and scores on the NU-6 (Northwestern University) monosyllabic word test increased from a preoperative mean of 3% (range, 0-20%) to a mean of 32% (range, 0-70%). More than two thirds (68%) of the adults were able to understand at least 50% of sentences over the telephone, and half were able to understand at least 75% of the sentence material.

CONCLUSIONS

The authors' institutional experience with the Clarion Multi-Strategy Cochlear Implant shows minimal surgical morbidity and significant improvement on all open-set test measures of sentence and word recognition.