Clinical Performance, Safety, and Patient-Reported Outcomes of an Active Osseointegrated Steady-State Implant System.

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.

Cochlear implant surgery and perioperative dizziness is associated with utricular hyperfunction.

BACKGROUND: Dizziness is a common perioperative complication after cochlear implantation (CI). To date, the exact cause behind this phenomenon remains unclear. There is recent evidence to suggest that otolith function, specifically utricular, may be affected shortly after CI surgery, however whether these changes are related to patient symptoms has not yet been investigated. OBJECTIVE: To determine whether CI surgery and perioperative dizziness is associated with changes in utricular function. METHODS: We performed an observational study on patients undergoing routine CI surgery. Utricular function was assessed using the Subjective Visual Vertical (SVV), and perioperative dizziness was determined using a questionnaire. The study followed patients before surgery and then again 1-day, 1-week and 6-weeks after implantation. RESULTS: Forty-one adult CI recipients participated in the study. The SVV deviated away from the operated ear by an average of 2.17° a day after implantation, 0.889° 1 week and -0.25° 6 weeks after surgery. Dizziness contributed to a tilt of 0.5° away from the implanted ear. These deviations were statistically significant. CONCLUSIONS: CI surgery causes utricular hyperfunction in the operated ear that resolves over 6 weeks. SVV tilts were greater in participants experiencing dizziness, suggesting that utricular hyperfunction may contribute to the dizziness.

Systemic methylprednisolone for hearing preservation during cochlear implant surgery: A double blinded placebo-controlled trial.

AIM: To assess whether a single, peri-operative, high dose of methylprednisolone can improve the preservation of residual acoustic hearing following cochlear implantation (CI). METHODS: This was a double blinded placebo-controlled trial, performed in a tertiary academic centre. The hypothesis was that methylprednisolone would improve the preservation of hearing, and lower electrode impedances. Adult patients (18-85 years) with hearing at 85 dB or better at 500 Hz in the ear to be implanted were randomly allocated to either treatment (methylprednisolone, 1g administered intravenously upon induction of anaesthesia) or control (normal saline infusion). As per standard clinical practice, all patients received a routine dose of dexamethasone (8 mg intravenously) on induction of anaesthesia. Implantation was undertaken with a slim and flexible lateral wall electrode via the round window. Surgical technique was routine, with adherence to soft surgical principles. The primary outcome was hearing preservation within 20 dB at 500 Hz, 12 months following cochlear implantation. Secondary outcomes included hearing preservation at 6 weeks and 3 months, monopolar electrode impedance, and Consonant-Vowel-Consonant (CVC) Phoneme scores at 3 and 12 months after surgery. RESULTS: Forty-five patients were enrolled into the control group and 48 patients received the steroid. The number of patients achieving hearing preservation at 12 months did not differ significantly between those receiving methylprednisolone treatment and the controls. There were no differences in hearing preservation at any frequency at either 6 weeks or 3 months after implantation. Neither CVC phoneme scores nor electrode impedances differed between the groups. CONCLUSIONS: This paper demonstrates that high-dose local steroid injection at surgery was not effective in preventing a loss of residual hearing, improving speech perception, or lowering electrode impedances. The findings were contrary to the experimental literature, and emerging clinical evidence that steroid elution from implant electrodes influences cochlear biology in humans. We found no evidence to support the widely-held practice of administering intravenous steroids in the perioperative period, in an attempt to preserve residual hearing.

Intraoperative Observational Real-time Electrocochleography as a Predictor of Hearing Loss After Cochlear Implantation: 3 and 12 Month Outcomes.

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.