Bone-Anchored Hearing Implant Loading at 3 Weeks

Faber, Hubert T.; Dun, Catharina A. J.; Nelissen, Rik C.; Mylanus, Emmanuel A. M.; Cremers, C.W.R.J.; Hol, Myrthe K. S.

doi:10.1097/mao.0b013e318277a282

Cited by 46 publications

(30 citation statements)

References 28 publications

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“…The six-month report showed higher mean Implant Stability Quotient (ISQ) values and less soft tissue reactions for the new, wider implant compared to the previous generation implant. The good outcomes could be confirmed in other studies [3][4][5] and in long term follow up [6], and resulted in a complete substitution of the previous generation implant in all new BAHI surgeries, not only in adult patients but also in the pediatric population. During the last few years, however, in both centers, we noticed a high incidence of soft tissue reactions, revision surgery and non-users in our pediatric BAHI population.…”

Section: Introductionsupporting

confidence: 52%

Clinical results of Cochlear™ BIA300 in children: Experience in two tertiary referral centers

Besten

Harterink

McDermott

et al. 2015

International Journal of Pediatric Otorhinolaryngology

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Section: Introductionsupporting

confidence: 52%

Clinical results of Cochlear™ BIA300 in children: Experience in two tertiary referral centers

Besten

Harterink

McDermott

et al. 2015

International Journal of Pediatric Otorhinolaryngology

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“…Given the high initial stability, and the fact that ISQ values are increased already at 10 days after implantation, earlier loading seems feasible, at least for patients with normal bone quality. Indeed, successful loading of wide diameter implants 3 to 4 weeks after surgery has recently been reported (18,20). There is some stability variance between the patients; this variance is mainly caused because of abutment length 9 mm on 3 patients.…”

Section: Discussionmentioning

confidence: 99%

A New Wide-Diameter Bone-Anchored Hearing Implant—Prospective 1-Year Data on Complications, Implant Stability, and Survival

Foghsgaard¹,

Cayé‐Thomasen²

2014

Otology &Amp; Neurotology

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ObjectiveTo investigate a new wide bone-anchored hearing implant considering initial stability, stability over time, implant loss, and skin reaction.Study DesignConsecutive, prospective case series.SettingTertiary referral center.PatientsTwenty adult patients were enrolled. All operations were 1-stage, single-incision technique with subcutaneous reduction.Intervention(s)Measurement of implant stability.Main Outcome Measure(s)Implant stability quotient (ISQ) values were recorded using resonance frequency analysis at the time of implantation and at 10 days, 6 weeks, 6 months, and 1 year after surgery. Skin and soft tissue reactions according to Holgers grading system.ResultsImplant stability quotient measurements revealed a significant increase in ISQ during the first 10 days after operation, and the ISQ values continued to rise throughout the 1-year observation period. No implants were lost. Skin and soft tissue reactions were rare and minor, as no reaction was seen in 93% of the follow-up examinations and no grade 4 reactions occurred.ConclusionThe new wide implant showed good stability at surgery. Osseointegration was fast, and implant stability increased throughout the 1-year observation period. No implants were lost. Skin and soft tissue reactions were rare and minor.

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“…A total of 62 participants will be recruited at the ear, nose and throat outpatient departments by the (local) researchers. Patients are considered eligible for participation [22, 39] (I) if they will undergo unilateral BCHI surgery and (II) when they are ≥ 18 years of age. Participants will be excluded from participation in case of (I) a history of immunosuppressive disease, (II) usage of systemic immunosuppressive medication, (III) bilateral BCHI placement, (IV) relevant dermatological disease (e.g., psoriasis, severe eczema), (V) participation in other studies, and (VI) when no suitable site for a 4-mm-wide implantation during surgery is found.…”

Section: Methodsmentioning

confidence: 99%

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

Calon

Hoof

Berge

et al. 2016

Trials

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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.

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Bone-Anchored Hearing Implant Loading at 3 Weeks

Cited by 46 publications

References 28 publications

Clinical results of Cochlear™ BIA300 in children: Experience in two tertiary referral centers

Clinical results of Cochlear™ BIA300 in children: Experience in two tertiary referral centers

A New Wide-Diameter Bone-Anchored Hearing Implant—Prospective 1-Year Data on Complications, Implant Stability, and Survival

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

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