A Multinational Cost-Consequence Analysis of a Bone Conduction Hearing Implant System-A Randomized Trial of a Conventional vs. a Less Invasive Treatment With New Abutment Technology.

Background: It is hypothesized that, for patients with hearing loss, surgically placing an implant/abutment combination whilst leaving the subcutaneous tissues intact will improve cosmetic and clinical results, increase quality of life (QoL) for the patient, and reduce medical costs. Here, incremental costs and consequences associated with soft tissue preservation surgery with a hydroxyapatite (HA)-coated abutment (test) were compared with the conventional approach, soft tissue reduction surgery with an all-titanium abutment (control). Methods: A cost-consequence analysis was performed based on data gathered over a period of 3 years in an open randomized (1:1) controlled trial (RCT) running in four European countries (The Netherlands, Spain, France, and Sweden). Subjects with conductive or mixed hearing loss or single-sided sensorineural deafness were included. Results: During the first year, in the Netherlands (NL), France (FR), and Spain (ES) a net cost saving was achieved in favor of the test intervention because of a lower cost associated with surgery time and adverse event treatments [NL €86 (CI -50.33; 219.20), FR €134 (CI -3.63; 261.30), ES €178 (CI 34.12; 97.48)]. In Sweden (SE), the HA-coated abutment was more expensive than the conventional abutment, which neutralized the cost savings and led to a negative cost (SE €-29 CI -160.27; 97.48) of the new treatment modality. After 3 years, the mean cost saving reduced to €17 (CI -191.80; 213.30) in the Netherlands, in Spain to €84.50 (CI -117.90; 289.50), and in France to €80 (CI -99.40; 248.50). The mean additional cost in Sweden increased to €-116 (CI -326.90; 68.10). The consequences in terms of the subjective audiological benefit and Health-related quality of life (HRQoL) were comparable between treatments. A trend was identified for favorable results in the test group for some consequences and statistical significance is achieved for the cosmetic outcome as assessed by the clinician. Conclusions: From this multinational cost-consequence analysis it can be discerned that health care systems can achieve a cost saving during the first year that regresses after 3 years, by implementing soft tissue preservation surgery with a HA-coated abutment in comparison to the conventional treatment. The cosmetic results are better. (sponsored by Cochlear Bone Anchored Solutions AB; Clinical and health economic evaluation with a new Baha® abutment design combined with a minimally invasive surgical technique, ClinicalTrials.gov NCT01796236).

Minimally Invasive Ponto Surgery compared to the linear incision technique without soft tissue reduction for bone conduction hearing implants: study protocol for a randomized controlled trial.

BACKGROUND: Over the last years, less invasive surgical techniques with soft tissue preservation for bone conduction hearing implants (BCHI) have been introduced such as the linear incision technique combined with a punch. Results using this technique seem favorable in terms of rate of peri-abutment dermatitis (PAD), esthetics, and preservation of skin sensibility. Recently, a new standardized surgical technique for BCHI placement, the Minimally Invasive Ponto Surgery (MIPS) technique has been developed by Oticon Medical AB (Askim, Sweden). This technique aims to standardize surgery by using a novel surgical instrumentation kit and minimize soft tissue trauma. METHODS: A multicenter randomized controlled trial is designed to compare the MIPS technique to the linear incision technique with soft tissue preservation. The primary investigation center is Maastricht University Medical Center. Sixty-two participants will be included with a 2-year follow-up period. Parameters are introduced to quantify factors such as loss of skin sensibility, dehiscence of the skin next to the abutment, skin overgrowth, and cosmetic results. A new type of sampling method is incorporated to aid in the estimation of complications. To gain further understanding of PAD, swabs and skin biopsies are collected during follow-up visits for evaluation of the bacterial profile and inflammatory cytokine expression. The primary objective of the study is to compare the incidence of PAD during the first 3 months after BCHI placement. Secondary objectives include the assessment of parameters related to surgery, wound healing, pain, loss of sensibility of the skin around the implant, implant extrusion rate, implant stability measurements, dehiscence of the skin next to the abutment, and esthetic appeal. Tertiary objectives include assessment of other factors related to PAD and a health economic evaluation. DISCUSSION: This is the first trial to compare the recently developed MIPS technique to the linear incision technique with soft tissue preservation for BCHI surgery. Newly introduced parameters and sampling method will aid in the prediction of results and complications after BCHI placement. TRIAL REGISTRATION: Registered at the CCMO register in the Netherlands on 24 November 2014: NL50072.068.14 . Retrospectively registered on 21 April 2015 at ClinicalTrials.gov: NCT02438618 . This trial is sponsored by Oticon Medical AB.

Predictors of hearing acuity: cross-sectional and longitudinal analysis.

BACKGROUND: This study aimed to identify predictors of hearing thresholds (best-ear pure-tone average at 1, 2, and 4 kHz) and hearing deterioration in order to define potential target groups for hearing screening. METHODS: We analyzed data from the Maastricht Aging Study, a Dutch cohort (aged 24-81 years; N = 1,721) that was observed for 12 years. Mixed model analysis was used to calculate each participant's average hearing threshold deterioration rate during the follow-up period. We built ordinary least square linear regression models to predict the baseline threshold and deterioration rate. Potential predictors included in these models were age, gender, type of occupation, educational level, cardiovascular disease, diabetes, systemic inflammatory disease, hypertension, obesity, waist circumference, smoking, and physical activity level. We also examined the relationship between baseline threshold and the deterioration rate. RESULTS: Poorer baseline thresholds were strongly associated with faster hearing deterioration. Higher age, male gender, manual occupation, and large waist circumference were statistically significantly associated with poorer baseline thresholds and faster deterioration, although the effects of occupation type and waist circumference were small. CONCLUSIONS: This study indicates that age and gender must be taken into account when determining the target population for adult hearing screening and that the time interval between repeated screenings should be based either on age or on the hearing thresholds at the first screening.

Screening for hearing loss versus parental concern regarding hearing problems: Subsequent referral and treatment for otitis media in the Netherlands.

OBJECTIVE: The present study investigates whether general practitioner (GP) consultation initiated by failing the population hearing screening at age nine months or GP consultation because of parental concern over ear/hearing problems was more important in deciding on referral and/or surgical treatment of otitis media (OM). DESIGN: A questionnaire covering the history between birth and 21 months of age was used to obtain information on referral after failing the hearing screening, GP consultations for ear/hearing problems, and subsequent referral to a specialist and possible surgical treatment at an ENT department. SETTING: The province of Limburg, the Netherlands. SUBJECTS: Healthy infants invited for the hearing screening at age nine months, who responded in an earlier study called PEPPER (Persistent Ear Problems, Providing Evidence for Referral, response rate 58%). MAIN OUTCOME MEASURES: The odds of a child being surgically treated for OM. RESULTS: The response rate for the present questionnaire was 72%. Of all children tested, 3.9% failed the hearing screening and were referred to their GP. Of all 2619 children in this study, 18.6% visited their GP with ear/hearing problems. Children failing the hearing screening without GP consultation for ear/hearing problems were significantly more often treated surgically for OM than children passing the hearing screening but with GP consultation for ear/hearing problems. CONCLUSION: Objectified hearing loss, i.e. failing the hearing screening, was important in the decision for surgical treatment in infants in the Netherlands.

Risk factors for failing the hearing screen due to otitis media in Dutch infants.

Hearing loss from otitis media (OM) can affect young children's development. Some children with persistent OM-related hearing loss and associated problems can benefit from treatment, but researchers and clinicians are still unclear on how to identify them best. The present study aims to determine which factors are most related to the hearing loss in OM, as a first step towards an effective case-finding instrument for detecting infants with persistent OM-related hearing loss. The full PEPPER ('Persistent Ear Problems, Providing Evidence for Referral') item pool includes a wide range of risk factors for OM in a single questionnaire, and is easily completed by parents or guardians. The questionnaire was sent to all children invited for the universal hearing screen at age 9 months in Limburg, The Netherlands. Repeatedly failing of the hearing screen was used as outcome marker indicative of OM-related chronic hearing loss. Univariate analyses were conducted to determine statistically significant risk factors predicting 'fail' cases at this hearing screen. Five items were found as individually predictive of hearing screen failure and subsequent referral: 'having severe cold symptoms', 'attending day care with >4 children', 'having siblings', 'severe nasal congestion' and 'male gender'. Suitably worded parental questions document risk factors for OM-related hearing loss in infants, broadly consistent with past general literature on OM risk factors, but more focused. The findings justify further optimising and evaluation of an additive or multiplicative combination of these questions as a means for selecting and routing an infant with diagnosed or suspected OM to further care.

Interventions following hearing screening in adults: a systematic descriptive review.

OBJECTIVE: Adult hearing screening may be a solution to the under-diagnosis and under-treatment of hearing loss in adults. Limited use and satisfaction with hearing aids indicate that consideration of alternative interventions following hearing screening may be needed. The primary aim of this study is to provide an overview of all intervention types that have been offered to adult (≥ 18 years) screen-failures. DESIGN: Systematic literature review. Articles were identified through systematic searches in PubMed, EMBASE, Cinahl, the Cochrane Library, private libraries, and through reference checking. RESULTS: Of the initial 3027 papers obtained from the searches, a total of 37 were found to be eligible. The great majority of the screening programmes (i.e. 26) referred screen-failures to a hearing specialist without further rehabilitation being specified. Most of the others (i.e. seven) led to the provision of hearing aids. Four studies offered alternative interventions comprising communication programme elements (e.g. speechreading, hearing tactics) or advice on environmental aids. CONCLUSIONS: Interventions following hearing screening generally comprised referral to a hearing specialist or hearing aid rehabilitation. Some programmes offered alternative rehabilitation options. These may be valuable as an addition to or replacement of hearing aid rehabilitation. It is recommended that this be addressed in future research.

Psychometric evaluation of the OM8-30 questionnaire in Dutch children with otitis media.

The Dutch translation of the OM8-30 questionnaire, originally developed in the UK on a large clinical sample, has been applied for validation in an ENT sample, with the aim of assessing otitis media impact and identifying treatment needs in children suffering from chronic otitis media (OM) and/or upper respiratory tract infections (URTI). Caregivers of 246 children completed the OM8-30 and also the generic Strengths and Difficulties Questionnaire (SDQ), prior to otolaryngologist consultation. Factor analysis confirmed the hypothesized six-factor structure, accounting for 55.5% of the variance. The internal consistency was satisfactory to good for all of the physical and developmental facets (alpha-values > or = 0.68). The correlation matrix with the SDQ scales and total difficulties score showed significant relationships for almost all of the OM8-30 developmental facets and sub-aggregate (Ps < 0.01), supporting the concurrent validity of the OM8-30 as a measure of impact in otitis media. This first examination of the Dutch OM8-30 shows that the psychometric characteristics are sufficiently good for the assessment of disease impact, and that this can be subdivided into impact on physical health and on developmental aspects. Recommendations for further research include the study of confounders such as hearing, age and previous operations so that these can be adjusted out, and the determination of which subgroup of children may benefit from tympanostomy tubes.

Response-shift bias and parent-reported quality of life in children with otitis media.

OBJECTIVES: To validate the 6-item quality-of-life survey (OM-6) and to investigate response-shift bias regarding children with otitis media. SETTING: Otorhinolaryngology department of a university hospital that serves the southernmost part of the Netherlands. PATIENTS: Seventy-seven children (age range, 12-38 months) experiencing persistent otitis media with effusion and scheduled for placement of tympanostomy tubes. SURVEY: The OM-6 measures health-related quality of life in 6 domains: physical suffering, hearing loss, speech impairment, emotional distress, activity limitations, and caregiver concerns. INTERVENTION: Parents completed the OM-6 before surgery (pretest) and 6 weeks after surgery (posttest). At the posttest, parents also completed a retrospective version of the pretest (retrospective pretest). RESULTS: For most items, the test-retest reliability was good (R>0.8). The internal consistency of the OM-6 was satisfactory (alpha =.79). The construct validity, determined by correlating the ear-related global quality-of-life measure and the OM-6 summary score, was fair (R = -0.77, P<.01). Prospective change in quality of life on the OM-6 ranged from moderate (standardized response mean >/=0.5) to large (standardized response mean >/=0.8). Response-shift bias was present at the group level (t = -3.3, P<.01). Retrospective change was significant for hearing loss (z = -3.3, P<.05) and ear-related global quality of life (z = -3.6, P<.05). CONCLUSIONS: The validity of the OM-6 has been proved in a Dutch population. The data suggest that parents underestimate the seriousness of hearing loss and overestimate the quality of life of their child before surgery, indicating a response shift. Treatment results could lead parents to realize that the situation before surgery had been worse than they thought.

The cost-effectiveness of hearing-aid fitting in the Netherlands.

OBJECTIVE: To determine the cost-effectiveness of hearing-aid fitting. DESIGN: Cost-effectiveness analysis using a Markov model based on aggregate data and results from a prospective intervention study. SETTING: The cost-effectiveness study was based in the general community. The prospective study was hospital based, as 85% of the first-time hearing-aid users attend a hospital in the process of hearing-aid fitting. PATIENTS: The prospective intervention study included adult first-time hearing-aid users with no contraindications for hearing-aid use. INTERVENTION: The usual process of hearing-aid fitting in the Netherlands. MAIN OUTCOME MEASURE: Costs per quality-adjusted life-year (QALY). The QALYs were based on EuroQol scores. We included direct and indirect costs in the analysis. RESULTS: The mean improvement on the EuroQol measure was 0.03 (95% confidence interval [CI], -0.03 to 0.08), and on the hearing-specific visual analog scale, 0.27 (95% CI, 0.22-0.31). The base-case outcome based on the EuroQol was 15 807/QALY (US dollars 17 072/QALY) (CI, -24 239/QALY to 3718/QALY). CONCLUSIONS: On the basis of this base-case estimate, fitting of hearing aids is considered a cost-effective health care intervention. The CI indicates that the result is not unambiguously positive, probably because the EuroQol lacked sensitivity for the evaluation of hearing-aid fitting. Until now, no study has found an effect of hearing-aid fitting on generic quality of life. Therefore, measures are needed that are suitable for the evaluation of the effects of interventions for sensory disabilities, such as the fitting of hearing aids, on generic quality of life.