Clinical Outcomes for Adult Single-Sided Deafness Cochlear Implantees Exceeding the 5% Candidacy Criterion

Objectives: While single-sided deafness cochlear implants (SSD-CIs) have now received regulatory approval in the United States, candidate-ear candidacy criteria (no better than 5% word-recognition score) are stricter than for traditional CI candidates (50 to 60% speech recognition, best-aided condition). SSD implantation in our center began before regulatory approval, using a criterion derived from traditional candidacy: 50% consonant-nucleus-consonant (CNC) word-identification score in the candidate ear. A retrospective analysis investigated whether SSD patients exceeding the 5% CNC criterion nevertheless benefitted from a CI as assessed by spatial-hearing tests (speech understanding in noise [SIN] and localization) and by a patient-reported outcome measure quality-of-life instrument validated for patients with CIs. Design: A retrospective chart review assessed the clinical experience of a single CI center. Subjects consisted of 27 adult CI recipients with SSD (N = 21) or asymmetric hearing loss (AHL; N = 6) implanted since September 2019 with at least 3 months of postoperative follow-up. Patients with revision surgery or simultaneous labyrinthectomy and CI surgery were excluded from the sample. Subjects were divided into 2 groups based on preoperative CNC scores measured under best-aided conditions with a behind-the-ear hearing aid in the sound field at 0.9 m from a front loudspeaker, and the better ear masked using an insert earphone with 45 dB HL speech-weighted noise. The "MEETS" group had preoperative CNC word scores <5%; the "EXCEEDS" group had scores >5%. The clinical protocol also included intelligibility tests using AzBio sentences in the same test conditions as CNC; binaural spatial testing (broadband-noise sound localization, and matrix-sentence speech-reception thresholds in spatially separated noise) using a custom-built 7-speaker array; and the CI Quality of Life (CIQOL) instrument. To evaluate CI benefit, preoperative unaided performance was compared with postoperative binaural (acoustic ear + CI ear) performance at a clinic visit closest to 6 months postsurgery. Results: Of 27 SSD-CI recipients, 11 subjects exceeded the 5% preoperative CNC candidacy criterion. Both the MEETS and EXCEEDS groups improved significantly on all 5 primary study outcome measures (CI-alone CNC and AzBio, binaural SIN and sound localization, and CIQOL). The only statistically significant differences observed between the MEETS and EXCEEDS groups were that preoperative CNC and AzBio scores were significantly higher for the EXCEEDS group, as expected given that the groups were defined based on preoperative speech-perception scores in quiet. There were no statistically significant differences between the MEETS and EXCEEDS groups in postoperative scores in any test or in the magnitude of the improvement from preoperative to postoperative assessment. Conclusions: SSD- and AHL-CI recipients exceeding the 5% CNC preoperative candidacy criterion significantly improved in CI-alone speech perception, spatial hearing, and subjectively reported CIQOL outcomes and the observed benefits were indistinguishable from SSD- and AHL-CI recipients who met the 5% criterion. A less-restrictive SSD-CI and AHL-CI candidacy criterion should be considered, and larger-scale clinical trials to evaluate CI efficacy using a less-stringent candidate-ear criterion are warranted.