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Objective: To investigate the clinical performance, safety, and patient-reported outcomes of an active osseointegrated steady-state implant system that uses piezoelectric technology., Study Design: A prospective, multicenter, open-label, single-arm, within-subject clinical investigation., Setting: Three tertiary referral clinical centers located in Melbourne, Sydney, and Hong Kong., Patients: Twenty-nine adult subjects, 24 with mixed hearing loss or conductive hearing loss and 5 with single-sided sensorineural deafness., Intervention: Implantation with the Cochlear Osia 2 System., Main Outcome Measures: Audiological threshold evaluation and speech recognition in quiet and in noise. Patient satisfaction and safety., Results: At 6-month follow-up after surgery, a mean improvement in pure-tone average of 26.0 dB hearing level and a mean improvement of 8.8 dB signal-to-noise ratio in speech reception threshold in noise was achieved with the investigational device as compared with the unaided situation. Usability of the investigational device was rated 71.4/100 mm for sound processor retention and 81.4/100 mm for overall comfort using a visual analog scale., Conclusion: These outcomes confirm the clinical safety, performance, and benefit of an innovative active transcutaneous bone conduction implant using a piezoelectric transducer design in subjects with conductive hearing loss, mixed hearing loss, or single-sided sensorineural deafness., (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of Otology & Neurotology, Inc.)

Objective: A decrease in intracochlear electrocochleographic (ECochG) amplitude during cochlear implantation has been associated with poorer postoperative hearing preservation in several short-term studies. Here, we relate the stability of ECochG during surgery to hearing preservation at 3- and 12-months., Methods: Patients with hearing ≤80-dB HL at 500 Hz were implanted with a slim-straight electrode array. ECochG responses to short, high-intensity, 500-Hz pure tones of alternating polarity were recorded continuously from the apical-most electrode during implantation. No feedback was provided to the surgeon. ECochG amplitude was derived from the difference response, and implantations classified by the presence ("ECochG drop") or absence ("no drop") of a ≥30% reduction in ECochG amplitude during insertion. Residual hearing (relative and absolute) was reported against the ECochG class., Results: ECochG was recorded from 109 patients. Of these, interpretable ECochG signals were recorded from 95. Sixty-six of 95 patients had an ECochG drop during implantation. Patients with an ECochG drop had poorer preoperative hearing above 1000 Hz. Hearing preservation (in decibels, relative to preoperative levels and functionally) was significantly poorer at 250-, 500-, and 1000-Hz at 3 months in patients exhibiting an ECochG drop. Twelve-month outcomes were available from 85 patients, with significantly poorer functional hearing, and greater relative and absolute hearing loss from 250 to 1000 Hz, when an ECochG drop had been encountered., Conclusion: Patients exhibiting ECochG drops during implantation had significantly poorer hearing preservation 12 months later. These observational outcomes support the future development of surgical interventions responsive to real-time intracochlear ECochG. Early intervention to an ECochG drop could potentially lead to prolonged improvements in hearing preservation.

Objective: To describe the tip fold over rate, scalar localization, and speech perception outcomes of the CI532 Slim Modiolar Electrode., Patients and Intervention: All patients receiving the CI532 implant before June 2018., Main Outcome Measures: Outcome measures for adults patients include pre- and postoperative speech perception, operative report details, electrode position as determined by X-ray and cone beam computed tomography. Comparison made with previous experience with the Contour perimodiolar electrode (CI512). In the pediatric population tip fold-over rate, measured by intraoperative X-ray, was the exclusive outcome., Results: One hundred twenty-five CI532 devices were implanted in adults and 69 in children. Electrode tip fold-over occurred in eight adults cases and none among children (4.1%). Cone beam CT scans of 120 out of 125 adult patients confirmed scala tympani (ST) position in all but one case where the electrode had been placed into scala vestibuli. There were no translocations from ST to scala vestibuli. This compares favorably with the CI512 translocation rate of 17%. Speech perception outcomes demonstrated good performance with mean preop phoneme scores of 16.2% (±13) increasing to 64.2% (±14) and 71.6 (±16) 3 and 12-months postop, respectively. Compared with a matched group of CI512 recipients, CI532 recipient phoneme scores were significantly higher 3 and 12-months postop by 4 and 7%, respectively., Conclusion: The slim modiolar, CI532 electrode has provided very reliable ST position with a low rate of tip fold over. A trend toward better speech perception scores in CI532 compared with CI512 was observed.

Objectives: To document incidences of vestibular dysfunction after cochlear implantation and investigate why it occurs. This work was also motivated by a desire to provide the basis for better preoperative counseling and postoperative vestibular therapy to cochlear implant patients., Setting: Melbourne Cochlear Implant Clinic at a tertiary referral hospital., Study Design: Prospective observational study., Patients: One hundred forty-six adult implant recipients, mean age, 60 years (range, 20-90 yr)., Main Outcome Measures: Postoperative vestibular disturbance was defined as symptoms lasting for 1 week or longer after surgery. The differences in preoperative and postoperative vestibular function were measured from subjective assessments (Dizziness Handicap Inventory and Activity Balance Confidence questionnaires) and objective assessments (bithermal caloric tests). The position of the postoperative electrode was classified as "loose", "regular", or "tight" fitting., Results: Thirty-two percent of patients reported vestibular disturbance and had poorer Dizziness Handicap Inventory, Activity Balance Confidence, and caloric results in the implanted ear after surgery. Patient age, cause, and preoperative caloric result did not predict postoperative vestibular symptoms. Recipients aged 70 years or older had significantly poorer caloric results on the implanted side after surgery that was not related to the intracochlear electrode position or surgical team., Conclusion: One-third of recipients can expect to experience a significant vestibular disturbance after surgery, regardless of age, cause, or preoperative caloric result. "Older" ears seem more prone to permanent injury after cochlear implantation.