Next-Day Loading of a Bone-Anchored Hearing System: Preliminary Results.

OBJECTIVES: To demonstrate the feasibility and efficacy for next-day loading of a percutaneous bone-anchored hearing device. STUDY DESIGN: Multicenter prospective cohort study. SETTING: Tertiary neurotologic referral centers. SUBJECT AND METHODS: In this multicenter prospective study, a 4.5-mm laser-etched bone-anchored hearing device was implanted in adult subjects who had conductive/mixed hearing loss or single-sided deafness. One day following implantation, the surgical site was assessed for soft tissue reaction per the Holgers Scale, and implant stability was evaluated by manual palpation and resonance frequency analysis. On the same day, subjects were fitted with the processor. Follow-up evaluations were at 1 week, 4 weeks, 3 months, 6 months, and 12 months. The Glasgow Benefit Inventory and Abbreviated Profile of Hearing Aid Benefit questionnaires were completed postoperatively. RESULTS: Fourteen devices were implanted in 12 subjects. Two subjects underwent bilateral implantation. Implant stability was rated as firm at every interval for all ears, and the Implant Stability Quotient values at 3 months were stable or increased as compared with day 1 measurements. Skin irritation was limited to Holgers grade 0 and 1, with the majority having no skin irritation. The mean Glasgow Benefit Inventory global score was +43.8, and the mean Abbreviated Profile of Hearing Aid Benefit global benefit score was 60.2%. All 14 implants have remained firmly anchored. CONCLUSIONS: Next-day loading of this 4.5-mm-diameter percutaneous bone-anchored hearing device appears to be a feasible alternative to the original 3-month delayed loading. Although this is a preliminary study, the results support continued investigation of a next-day loading strategy.

Quality of life instruments in Ménière's disease.

OBJECTIVE: Evaluate the sensitivity of quality of life (QoL) instruments over time in patients with Ménière's disease using general, symptom-specific, and disease-specific QoL instruments. STUDY DESIGN: Prospective study using QoL instruments administered serially over 4 months in patients undergoing treatment for Ménière's disease. METHODS: Sixty-one people aged 33 to 71 years with active, unilateral, cochleovestibular Ménière's disease refractory to medical management completed two general QoL instruments, Sense of Coherence (SOC) and World Health Organization Quality of Life-Abbreviated Version (WHOQOL-BREF), one symptom-specific QoL instrument, Vertigo Symptom Scale (VSS), and one disease-specific QoL instrument, Ménière's Disease Patient Oriented Severity Index (MDPOSI). All measures were administered at baseline and again 2 and 4 months later. RESULTS: Disease- and symptom-specific instruments including the MDPOSI and VSS were positively correlated with vertigo control category (Pearson's R=0.345, MDPOSI; 0.279, VSS), indicating sensitivity to the frequency of vertigo spells. These instruments were also sensitive to changes in vertigo over time. Standardized response means showed greatest responsiveness to change on the MDPOSI (0.80) and the VSS (0.79). Standardized response means for SOC and WHOQOL-BREF were 0.03, and 0.32, respectively, suggesting poor responsiveness to change of symptoms. The VSS and MDPOSI were highly correlated (Pearson's r coefficient 0.744; P<.001). CONCLUSIONS: A disease-specific QoL instrument such as the MDPOSI and a symptom-specific instrument such as the VSS more accurately reflect changes in control of vertigo in people with Ménière's disease over time than do general QoL instruments. These instruments can be used to determine the life impact of Ménière's disease and how aggressive therapy should be for the patient.

Next generation shape memory prosthesis (NiTiBOND) for stapedotomy: Short-term results.

OBJECTIVES/HYPOTHESIS: To review hearing results and complications for the NiTiBOND next generation shape memory prosthesis and compare them with results for the current shape memory prosthesis (SMart). STUDY DESIGN: Retrospective, multicenter chart review. METHODS: Primary laser stapedotomy was performed using either a NiTiBOND or a SMart prosthesis. Ninety-two ears in 79 patients were included in the study (67.4% female), 52 with the NiTiBOND prosthesis and 40 with the SMart prosthesis. Data collected included demographic variables, pre- and postoperative pure-tone air and bone conduction thresholds, speech discrimination scores, complications, and the need for revision surgery. Pure-tone average (PTA) and PTA air-bone gap (ABG) pre- and postoperative were computed. Success was defined as a postoperative ABG of ≤10 dB. RESULTS: There were no significant differences between groups in hearing results, including improvement in ABG, change in speech discrimination, change in air or bone PTA, or change in high-frequency bone PTA. Short-term (mean = 4.4 and 4.9 weeks, respectively) success rates for the NiTiBOND and SMart prostheses were 84.6% and 70.0%, respectively, with this difference closing at the most recent test (83.7% and 80.0%, respectively). No revision surgery took place in either group, and there were no differences in complications such as dizziness, tinnitus, or taste disturbance, though the NiTiBOND group tended to have a lower rate of transient or permanent vertigo. CONCLUSIONS: Compared with the SMart prosthesis, the NiTiBOND prosthesis is a safe prosthesis that achieves at least comparable hearing results and may offer some surgical advantages. LEVEL OF EVIDENCE: 4 Laryngoscope, 127:915-920, 2017.

Meniett clinical trial: long-term follow-up.

OBJECTIVE: To delineate 2-year efficacy of Meniett device therapy in people with classic, unilateral, Ménière's disease unresponsive to traditional medical treatment. DESIGN: A 2-year long-term unblinded follow-up after a prior randomized, placebo-controlled, multicenter clinical trial of the Meniett device for Ménière's disease. SETTING: Follow-up was performed remotely by using diaries and questionnaires mailed to the data coordinating center by the participants. Those who failed to mail their diaries were interviewed by telephone. PARTICIPANTS: Sixty-one study participants agreed to use the Meniett device and report their symptoms for 2 years. All had active, unilateral cochleovestibular disease. Outcomes are available for 58 participants; 2 were unavailable for follow-up and 1 was excluded because of a concurrent condition that precluded Meniett device use. INTERVENTIONS: Participants were advised to adhere to a low-sodium diet, use the Meniett device 3 times daily, and maintain a patent tympanostomy tube in the affected ear. Diuretic and vestibular suppressant medications were used as needed. MAIN OUTCOME MEASURES: Outcomes were based on the participants' daily diary, questionnaires, and telephone interviews. Three different analyses were prepared: tracking of vertigo frequency throughout the study, comparison of vertigo frequency before and at the end of Meniett device use (American Academy of Otolaryngology-Head and Neck Surgery Foundation reporting guideline), and Kaplan-Meier estimates of vertigo remission and recurrence. RESULTS: Vertigo levels gradually improved for most but not all participants. American Academy of Otolaryngology-Head and Neck Surgery Foundation class A (remission) or class B (greatly improved) results occurred in 67% (39/58) of participants, and class F (dropped out to receive surgical therapy) results occurred in 24%. Of the 44 nondropout participants, 39 (89%) had American Academy of Otolaryngology-Head and Neck Surgery Foundation group A or B outcomes. People who went into remission were highly likely (80%) to remain in remission long term; participants who achieved remission (20/43; 47%) did so within the first year of follow-up. CONCLUSIONS: Use of the Meniett device was associated with a significant reduction in vertigo frequency in about two thirds of the participants, and this improvement was maintained long term. Therapy with the Meniett device is a safe and effective option for people with substantial vertigo uncontrolled by medical therapy.

Intermittent pressure therapy of intractable Ménière's disease using the Meniett device: a preliminary report.

HYPOTHESIS: Treatment with the Meniett device, which applies intermittent micropressure pulses to the inner ear through a tympanostomy tube, is effective in controlling vertigo in people with intractable Ménière's disease. STUDY DESIGN: Short-term, preliminary descriptive report. METHODS: Ten patients with intractable vertigo despite adequate medical therapy elected to use the Meniett device. After placement of a standard tympanostomy tube, the patient self-administers the Meniett device three times daily. RESULTS: The follow-up ranged from 3 to 11 months with an average of 8 months. All 10 patients responded to the therapy with vertigo control in 9 of 10 and a 50% reduction in the 10th case. There was a mean hearing gain of 6 dB, which was statistically significant. There were no major complications. Two subjects required tube reinsertion during the 8 months of follow-up. CONCLUSIONS: Use of the Meniett device is an effective and safe option for people with intractable vertigo from Ménière's disease.

The effects of transtympanic micropressure treatment in people with unilateral Meniere's disease.

OBJECTIVE: To evaluate the efficacy of a portable low-intensity alternating pressure generator, the Meniett device, in controlling the symptoms of Ménière's disease. DESIGN: A randomized, placebo-controlled, double-blind, multicenter clinical trial of 4 months' duration. SETTING: Four study sites: 3 academic medical centers and 1 private practice. PATIENTS: Sixty-seven people aged 33 to 71 years with established, active, unilateral cochleovestibular Ménière's disease randomly assigned to a treatment or control group. Five cases were excluded (2 dropouts, 3 protocol violations), leaving 62 evaluable cases. INTERVENTION: The Meniett device was self-administered 3 times daily. The placebo Meniett device was identical but exerted no pressure. All participants had a tympanostomy tube inserted in the affected ear. MAIN OUTCOME MEASURES: Participants rated vertigo and activity each day on a symptom report card. Hearing tests, electrocochleography, and questionnaires were completed at baseline, 2 months, and 4 months. RESULTS: The treatment group experienced significantly less severe vertigo, fewer days with definitive vertigo, and fewer days lost from work (sick days) during the follow-up period than did the control group. Hearing and electrocochleographic results did not differ between the groups. Outcomes did not differ by age, gender, laterality, or duration of symptoms. Outcomes were affected by vestibular loss and baseline level of vertigo. The tympanostomy tube had no short-term effect on vertigo symptoms. There were no complications from using the Meniett device. CONCLUSION: The Meniett device is a minimally invasive, safe, and efficacious intermediate treatment for people with substantial vertigo uncontrolled by medical therapy.

Preliminary ossiculoplasty results using the Kurz titanium prostheses.

OBJECTIVE: Limitations in biocompatibility and hearing improvement with ossicular chain reconstruction prostheses are addressed with new, lightweight titanium prostheses designed to maximize visualization of the capitulum and footplate regions. The effectiveness of these new prostheses is being tested in a prospective multicenter study. STUDY DESIGN: Prospective case series. SETTING: Multicenter (8 sites), primarily tertiary private practice or academic otologic clinics. PATIENTS: A convenience sample of 31 patients undergoing ossiculoplasty, with 16 partial ossicular chain reconstructions using the Bell prosthesis and 15 total reconstructions using the Aerial prosthesis. INTERVENTION: Ossiculoplasty using new Kurz titanium prostheses. Cartilage was interposed between the tympanic membrane and the prosthesis. MAIN OUTCOME MEASURES: Air-bone gap for pure tone average and 3,000 and 4,000 Hz, assessed preoperatively and 3 months, 6 months, and 12 months postoperatively; percent of patients obtaining an air-bone gap of

Remote programming of cochlear implants: a telecommunications model.

OBJECTIVE: Evaluate the effectiveness of remote programming for cochlear implants. STUDY DESIGN: Retrospective review of the cochlear implant performance for patients who had undergone mapping and programming of their cochlear implant via remote connection through the Internet. METHODS: Postoperative Hearing in Noise Test and Consonant/Nucleus/Consonant word scores for 7 patients who had undergone remote mapping and programming of their cochlear implant were compared with the mean scores of 7 patients who had been programmed by the same audiologist over a 12-month period. Times required for remote and direct programming were also compared. The quality of the Internet connection was assessed using standardized measures. Remote programming was performed via a virtual private network with a separate software program used for video and audio linkage. RESULTS: All 7 patients were programmed successfully via remote connectivity. No untoward patient experiences were encountered. No statistically significant differences could be found in comparing postoperative Hearing in Noise Test and Consonant/Nucleus/Consonant word scores for patients who had undergone remote programming versus a similar group of patients who had their cochlear implant programmed directly. Remote programming did not require a significantly longer programming time for the audiologist with these 7 patients. CONCLUSION: Remote programming of a cochlear implant can be performed safely without any deterioration in the quality of the programming. This ability to remotely program cochlear implant patients gives the potential to extend cochlear implantation to underserved areas in the United States and elsewhere.

Translabyrinthine approach for acoustic tumor removal. 1992.

The translabyrinthine approach is the most direct route to the cerebellopontine angle. It is the preferred approach for removal of all tumors in patients with poor hearing and for large tumors when the likelihood of hearing preservation is slight. This approach offers the advantages of minimum cerebellar retraction, identification of the facial nerve proximally and medially, and the ability to repair immediately the facial nerve if it is severed during acoustic tumor removal. This approach has the lowest morbidity with regard to spinal fluid leaks and also postoperative headaches.