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Patient-Reported Outcomes From the United States Clinical Trial for a Hybrid Cochlear Implant
David C Kelsall1, Renée J G Arnold, Leonard Lionnet
1*Rocky Mountain Ear Center, Englewood, Colorado †Quorum Consulting, San Francisco, California ‡Icahn School of Medicine at Mount Sinai, New York, New York.
Objective:
To assess patient-reported outcomes (PROs) in individuals with significant residual low-frequency hearing and severe-to-profound high-frequency sensorineural hearing loss (SNHL) who received the hybrid cochlear implant (CI).
Study Design:
Prospective, multicenter, nonrandomized, single-arm repeated measures, single-subject design.
Setting:
Tertiary centers, ambulatory care.
Patients:
Fifty adults with severe-to-profound high-frequency SNHL and residual low-frequency hearing with aided word recognition scores between 10 and 60% in the ear to be implanted, and in the contralateral ear greater than or equal to implant ear less than or equal to 80%.
Intervention:
Therapeutic; hybrid CI.
Main Outcome Measures:
Speech, spatial and qualities of hearing scale (SSQ), device use questionnaire (DUQ), University of Washington Clinical Assessment of Music Perception (UW-CAMP) assessed preoperatively and after 6 and 12 (SSQ and DUQ only) months of hybrid CI use.
Results:
Significant improvements in mean SSQ ratings were demonstrated at 6 and 12 months postactivation overall and for domains related to speech hearing, spatial hearing, and sound quality. Significant improvement was also found for overall satisfaction on the DUQ and across a number of specific listening situations in addition to aspects related to social engagement. UW-CAMP pitch discrimination and melody and timbre recognition abilities were not compromised postoperatively, allowing hybrid subjects to maintain superior music perception abilities than typically observed with standard CIs.
Conclusions:
Patients who received the hybrid CI demonstrated significant PRO benefits on the SSQ and the DUQ after 6 and 12 months of CI use. In addition, given the opportunity to maintain useful low-frequency acoustic hearing, patients retained music listening abilities, as assessed by the UW-CAMP.
