Cost-Utility of Partially Implantable Active Middle Ear Implants for Sensorineural Hearing Loss: A Decision Analysis.

BACKGROUND: Partially implantable active middle ear implants (aMEIs) offer a solution for individuals who have mild to severe sensorineural hearing loss and an outer ear medical condition that precludes the use of hearing aids. When otherwise left untreated, individuals report a lower quality of life, which may further decrease with increasing disability. In the lack of cost-effectiveness studies and long-term data, there is a need for decision modeling. OBJECTIVE: To explore individual-level variance in resource utilization patterns following aMEI implantation. METHODS: A Markov model was developed and analyzed as microsimulation to estimate the incremental cost utility ratio (ICUR) of partially implantable aMEIs compared with no (surgical) intervention in individuals with sensorineural hearing loss and an outer ear medical condition in Australia. Cost data were derived mostly from the Medicare Benefit Schedule and effectiveness data from published literature. A third-party payer perspective was adopted, and a 5% discount rate was applied over a 10-year time horizon. RESULTS: Compared with baseline strategy, aMEIs yielded an incremental cost of Australian dollars (AUD) 13,339.18, incremental quality-adjusted life-year (QALY) of 1.35, and an ICUR of AUD 9,913.72/QALY. Of the respective number of simulated patients who visited each health state, 75.73% never had a minor adverse event, 99.82% did not experience device failure, and 97.75% did not cease to use their aMEIs. Probabilistic sensitivity analyses showed the ICUR to differ by only 0.95%. CONCLUSIONS: In the Australian setting, partially implantable aMEIs offer a safe and cost-effective solution compared with no intervention and are also well accepted by users.

Systematic review to evaluate the safety, efficacy and economical outcomes of the Vibrant Soundbridge for the treatment of sensorineural hearing loss.

Introduced in the late 90s, the active middle ear implant Vibrant Soundbridge (VSB) is nowadays used for hearing rehabilitation in patients with mild to severe sensorineural hearing loss (SNHL) unable to tolerate conventional hearing aids. In experienced hands, the surgical implantation is fast done, safe and highly standardized. Here, we present a systematic review, after more than 15 years of application, to determine the efficacy/effectiveness and cost-effectiveness, as well as patient satisfaction with the VSB active middle ear implant in the treatment of mild to severe SNHL. A systematic search of electronic databases, investigating the safety and effectiveness of the VSB in SNHL plus medical condition resulted in a total of 1640 papers. After removing duplicates, unrelated articles, screening against inclusion criteria and after in-depth screening, the number decreased to 37 articles. 13 articles were further excluded due to insufficient outcome data. 24 studies remained to be systematically reviewed. Data was searched on safety, efficacy and economical outcomes with the VSB. Safety-oriented outcomes included complication/adverse event rates, damage to the middle/inner ear, revision surgery/explant rate/device failure and mortality. Efficacy outcomes were divided into audiological outcomes, including hearing thresholds, functional gain, speech perception in quiet and noise, speech recognition thresholds, real ear insertion gain and subjective outcomes determined by questionnaires and patient-oriented scales. Data related to quality of life (QALY, ICER) were considered under economical outcomes. The VSB turns out to be a highly reliable and a safe device which significantly improves perception of speech in noisy situations with a high sound quality. In addition, the subjective benefit of the VSB was found to be mostly significant in all studies. Finally, implantation with the VSB proved to be a cost-effective and justified health care intervention.

Evaluation of cost-utility in middle ear implantation in the 'Nordic School': a multicenter study in Sweden and Norway.

CONCLUSION: Hearing restoration using an active middle ear implant (AMEI) is a highly cost-effective treatment for a selected group of patients with no other possibilities for auditory rehabilitation. OBJECTIVES: To evaluate the cost-utility of using an AMEI for hearing rehabilitation. METHODS: This was a prospective, multicenter, single-subject repeated study in six tertiary referral centers. Twenty-four patients with sensorineural (SNHL), conductive (CHL), and mixed hearing loss (MHL) were implanted with the AMEI Vibrant Soundbridge® (VSB) for medical reasons. All patients were previously rehabilitated with conventional hearing aids. Multiple validated quality of life patient questionnaires, Health Utilities Index (HUI 2 and 3), and Glasgow Hearing Aid Benefit Profile (GHABP) were used to determine the utility gain and quality adjusted life years (QALY). Directly related treatment costs for the implantation were calculated and related to utility gain and QALY. RESULTS: The cost/QALY for patients with SNHL was estimated at €7260/QALY, and for patients with C/MHL at €12 503/QALY.

Cost-effectiveness of implantable middle ear hearing devices.

OBJECTIVE: To assess the relation between cost and effectiveness of implantable middle ear hearing devices in patients with pure sensorineural hearing loss. DESIGN: Literature review. RESULTS: Four studies were identified that described the effect of middle ear implantation on quality of life in groups of at least 20 patients. Several different quality of life questionnaires were used. CONCLUSIONS: Our review demonstrated that middle ear implantation is a cost-effective health care intervention in patients with sensorineural hearing loss who suffered an additional therapy-resistant chronic external otitis.

Indications and candidacy for active middle ear implants.

Currently, there are two active middle ear implants available commercially: the Vibrant Soundbridge system and the Carina system. A third active middle ear implant, the Esteem, is under clinical evaluation. All devices are indicated for patients with moderate-to-severe hearing loss. Because active middle ear implants are directly coupled to middle ear structures, many of the problems that patients with conventional hearing aids report, such as acoustic feedback, occlusion, and irritation of the outer ear canal, are avoided. In addition, AMEI patients perform well in background noise. However, indications for AMEIs are selective and candidates should be carefully evaluated before surgery. Before considering an AMEI, patients should be provided with conventional hearing aids. Only when benefit is insufficient and audiological selection criteria are met is further candidacy evaluation indicated. Since Colletti described coupling the Vibrant Soundbridge directly onto the round window membrane in 2006, the indications for the Vibrant Soundbridge have expanded and the VSB is implanted in patients with conductive and mixed hearing losses. Patients have often undergone middle ear surgery before. Especially mixed hearing loss cases with 30-60 dB HL sensorineural hearing impairment and 30-40 dB HL air-bone gaps may be helped by this new application.

Estimated cost-effectiveness of active middle-ear implantation in hearing-impaired patients with severe external otitis.

OBJECTIVE: To determine the cost-effectiveness of middle-ear implantations in hearing-impaired patients with severe external otitis in the Netherlands. DESIGN: Cost-effectiveness analysis, using single-subject repeated measures of quality of life and total cost determinations. SETTING: Hospital based. Patients Moderately to severely sensorineurally hearing-impaired patients (n = 21) with severe chronic external otitis, eligible to receive a middle-ear implant. Main Outcome Measure Cost per quality-adjusted life-year (QALY), based on scores of the Medical Outcomes Study Short-Form Health()Survey (SF-36) generic quality of life questionnaire. Only direct costs were included in cost calculation of middle-ear implantation. RESULTS: Mean health utility gain was 0.046 (0.012-0.079) (P = .01) measured at the mental component of the SF-36. With a mean profitable time of 19.4 years and an overall cost of euro 14,354, minimal cost-effectiveness of middle-ear implantation was euro 16,085/QALY. CONCLUSION: Based on the cost per QALY, middle-ear implantation proved to be a cost-effective and justified health care intervention in the Netherlands.

The use of cortical bone grafts in ossiculoplasty. III: Audit of costs.

This paper describes the results of a comparative audit of the costs of using artificial prostheses and cortical bone. The costs of using a bone graft have been calculated by estimating the expenses incurred as a result of the additional time required for preparation of the grafts. The mean cost of preparing a graft was 29.10 pounds, while the mean cost of using a prosthesis was 65.01 pounds.