The ototronix MAXUM middle ear implant for severe high-frequency sensorineural hearing loss: Preliminary results.

OBJECTIVES/HYPOTHESIS: To report the preliminary results of the Ototronix MAXUM middle ear implant for treatment of severe high-frequency sensorineural hearing loss.

STUDY

DESIGN

Case series with chart review.

METHODS

Six consecutive ears with severe high-frequency sensorineural hearing loss (≥75 dB HL at 2, 3, and 4 kHz) and poor aided word recognition performance (≤60% single words) underwent implantation of the MAXUM system at a single, private otologic referral center. Primary outcome measures included frequency-specific functional gain and word recognition score improvement compared to optimally fitted hearing aids.

RESULTS

Six ears, in four adult patients (two female; median age 67.5 years) were included. The median unaided preoperative high-frequency pure-tone average (HFPTA) (2, 3, and 4 kHz) was 80.0 dB (range, 75.0-85.0 dB), and the median best-aided word recognition score was 48.0% (range, 24%-60%). The median HFPTA functional gain with the MAXUM system was 47.2 dB, a 25.0 dB improvement (range, 16.7-33.3 dB) (P = .03) over optimally fit hearing aids, and the median word recognition score with MAXUM was 81.5%, a 42.0% improvement (range, 20%-48%) (P = .03) with the MAXUM middle ear implant over optimally fitted hearing aids.

CONCLUSIONS

These preliminary data demonstrate that the MAXUM middle ear implant provides superior functional gain and word recognition scores in quiet for patients with severe high-frequency sensorineural hearing loss compared to optimally fitted hearing aids. Future studies with greater patient numbers and patient reported outcome measures are needed to confirm these promising but preliminary results.

LEVEL OF EVIDENCE: 4 Laryngoscope, 126:2124-2127, 2016.