Bone-Anchored Hearing Aid: A Comparison of Surgical Techniques

Objective: To determine which bone-anchored hearing aid (BAHA) implantation surgical technique is associated with the fewest major postoperative complications and shortest time between surgery and use of the BAHA. The techniques evaluated were 1) a free retroauricular "full-thickness" skin graft, 2) a pedicled parieto-occipital epidermal graft, 3) a dermatome-edicled parieto-occipital dermal graft, and 4) two broad pedicled local epidermal skin envelopes/skin flaps. Study Design: Retrospective case study. Setting: Tertiary referral center. Patients: One hundred forty-three patients who received a BAHA at Maastricht University Medical Center between November 1996 and January 2007. Number and mean age of patients in each group: Technique 1 (n = 30; mean age, 55 yr), Technique 2 (n = 45; mean age, 54 yr), Technique 3 (n = 47; mean age, 55 yr), and Technique 4 (n = 21; mean age, 54 yr). Main Outcome Measures: Cumulative proportion of implants that remained free of major complications versus follow-up interval, time between surgery and use of BAHA. Results: Technique 4 (2 broad pedicled local epidermal envelopes/skin flaps) has a significantly higher proportion of implants that remained free of major complications during first year of follow-up (91%; p = 0.021). Pairwise comparisons revealed that Technique 4 also has a significantly shorter time until use (2 mo) than Techniques 1 (2.5 mo), 2, and 3 (both 2.3 mo). Conclusion: Two broad pedicled, local epidermal envelopes/flaps are associated with significantly fewer major complications and have one of the shortest times between surgery and use of the BAHA. The use of a dermatome is not associated with fewer major complications. We recommend Technique 4 as the preferred standard in BAHA surgery to minimize complications, postoperative medication, discomfort, and cost

Compensating for Deviant Middle Ear Pressure in Otoacoustic Emission Measurements, Data, and Comparison to a Middle Ear Model

OBJECTIVE: Deviant middle ear pressure has a negative effect on the forward and backward transmission of stimulus and emissions through the middle ear. Resolving this deviant middle ear pressure is expected to lead to better middle ear transmission and, as a result of this, stronger otoacoustic emissions, which are better detectable. We investigated the effect of compensation o a deviant tympanic peak pressure on click-evoked otoacoustic emissions (CEOAEs). Second, we compared patient data to model predictions made by Zwislocki's middle ear model. SETTING: University Medical Center. PATIENTS: Fifty-nine children aged between 0.5 and 9 years (mean, 4.4 yr). INTERVENTION: Hearing investigations including CEOAE measurements at ambient and at compensated tympanic peak pressure (TPP). MAIN OUTCOME MEASURE: CEOAEs at ambient and compensated TPP. RESULTS: Compensation of TPP resulted in higher emission amplitudes below 2 kHz (increase of 8-11 dB). In addition, the compensated measurement showed an increased phase lag (up to one-fourth cycle). For ears with mild deviations of TPP, Zwislocki's model could describe these changes. Pressure compensation was well described by a compliance increase of the tympanic membrane, the malleus, and the incus. CONCLUSION: Compensating the ear canal pressure for negative tympanic peak pressure increased CEOAE amplitudes below 2 kHz and increased the phase lag. These changes can be predicted from an increase of the compliance of the tympanic membrane, incus, and malleus, as a consequence of the pressure compensation

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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-016-1662-0) contains supplementary material, which is available to authorized users

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)