Objective:To compare the surgical outcomes of the Minimally Invasive Ponto Surgery (MIPS) technique with those of the linear incision technique with soft-tissue preservation for bone-anchored hearing systems (BAHS).Design:Sponsor-initiated multicenter, open, randomized, controlled clinical trial.Setting:Maastricht University Medical Centre, Ziekenhuisgroep Twente and Medisch Centrum Leeuwarden, all situated in The Netherlands.Participants:Sixty-four adult patients eligible for unilateral BAHS surgery.Interventions Single-stage BAHS surgery with 1:1 randomization to the linear incision technique with soft-tissue preservation (control) or the MIPS (test) group.Primary and Secondary Outcome Measurements:Primary objective: compare the incidence of inflammation (Holgers Index ≥ 2) during 12 weeks’ follow-up after surgery. Secondary objectives: skin dehiscence, pain scores, loss of sensibility around the implant, soft-tissue overgrowth, skin sagging, implant extrusion, cosmetic results, surgical time, wound healing and Implant Stability Quotient measurements.Results:Sixty-three subjects were analyzed in the intention-to-treat population. No significant difference was found for the incidence of inflammation between groups. Loss of skin sensibility, cosmetic outcomes, skin sagging, and surgical time were significantly better in the test group. No statistically significant differences were found for dehiscence, pain, and soft-tissue overgrowth. A nonsignificant difference in extrusion was found for the test group. The Implant Stability Quotient was statistically influenced by the surgical technique, abutment length, and time.Conclusion:No significant differences between the MIPS and the linear incision techniques were observed regarding skin inflammation. MIPS results in a statistically significant reduction in the loss of skin sensibility, less skin sagging, improved cosmetic results, and reduced surgical time. Although nonsignificant, the implant extrusion rate warrants further research.

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BackgroundOver 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.MethodsA 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.DiscussionThis 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 registrationRegistered 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 materialThe online version of this article (doi:10.1186/s13063-016-1662-0) contains supplementary material, which is available to authorized users.

The aim of this study was to compare listening effort, as estimated via pupillary response, during a speech-in-noise test in boneanchored hearing system (BAHS) users wearing three different sound processors. The three processors, Ponto Pro (PP), Ponto 3 (P3), and Ponto 3 SuperPower (P3SP), differ in terms of maximum force output (MFO) and MFO algorithm. The hypothesis was that listeners would allocate lower listening effort with the P3SP than with the PP, as a consequence of a higher MFO and, hence, fewer saturation artifacts in the signal. Design: Pupil dilations were recorded in 21 BAHS users with a conductive or mixed hearing loss, during a speech-in-noise test performed at positive signal-to-noise ratios (SNRs), where the speech and noise levels were individually adjusted to lead to 95% correct intelligibility with the PP. The listeners had to listen to a sentence in noise, retain it for 3 seconds and then repeat it, while an eye-tracking camera recorded their pupil dilation. The three sound processors were tested in random order with a single-blinded experimental design. Two conditions were performed at the same SNR: Condition 1, where the speech level was designed to saturate the PP but not the P3SP, and condition 2, where the overall sound level was decreased relative to condition 1 to reduce saturation artifacts. Results: The P3SP led to higher speech intelligibility than the PP in both conditions, while the performance with the P3 did not differ from the performance with the PP and the P3SP. Pupil dilations were analyzed in terms of both peak pupil dilation (PPD) and overall pupil dilation via growth curve analysis (GCA). In condition 1, a significantly lower PPD, indicating a decrease in listening effort, was obtained with the P3SP relative to the PP. The PPD obtained with the P3 did not differ from the PPD obtained with the other two sound processors. In condition 2, no difference in PPD was observed across the three processors. The GCA revealed that the overall pupil dilation was significantly lower, in both conditions, with both the P3SP and the P3 relative to the PP, and, in condition 1, also with the P3SP relative to the P3. Conclusions: The overall effort to process a moderate to loud speech signal was significantly reduced by using a sound processor with a higher MFO (P3SP and P3), as a consequence of fewer saturation artifacts. These findings suggest that sound processors with a higher MFO may help BAHS users in their everyday listening scenarios, in particular in noisy environments, by improving sound quality and, thus, decreasing the amount of cognitive resources utilized to process incoming speech sounds.

The Mel-Frequency Cepstral Coefficient (MFCC) or Perceptual Linear Prediction (PLP) feature extraction typically used for automatic speech recognition (ASR) employ several principles which have known counterparts in the cochlea and auditory nerve: frequency decomposition, mel-or bark-warping of the frequency axis, and compression of amplitudes. It seems natural to ask if one can profitably employ a counterpart of the next physiological processing step, synaptic adaptation. We therefore incorporated a simplified model of short-term adaptation into MFCC feature extraction. We evaluated the resulting ASR performance on the AURORA 2 and AURORA 3 tasks, in comparison to ordinary MFCCs, MFCCs processed by RASTA, and MFCCs processed by cepstral mean subtraction (CMS), and both in comparison to and in combination with Wiener filtering. The results suggest that our approach offers a simple, causal robustness strategy which is competitive with RASTA, CMS and Wiener filtering and performs well in combination with Wiener filtering. Compared to the structurally related RASTA, our adaptation model provides superior performance on AURORA 2 and, if Wiener filtering is used prior to both approaches, on AURORA 3 as well.