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A Cleveland Clinic study presented at the 2025 ACIA meeting evaluated 113 adults who received cochlear implants outside of the FDA’s current candidacy criteria. The patients, treated between 2021 and 2024, often had better contralateral ear performance or higher speech perception scores than the FDA indications allow. Results showed consistent and significant improvements in speech recognition in both quiet and noisy environments. The study also found that loss of residual hearing following surgery did not harm overall outcomes, and patients benefited even when their non-implanted ear performed relatively well.
The researchers argue that outdated FDA labeling and restrictive insurance policies could potentially exclude many individuals who could benefit, which contributes to the low rate of cochlear implant adoption in the U.S. They recommend adopting the American Cochlear Implant Alliance’s guideline of using ear-specific CNC word scores of 50% or less to guide candidacy. A multicenter trial is now underway to confirm these results, with the goal of persuading regulators and payers to broaden indications so that more patients can gain access earlier in their hearing loss journey.
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