Evaluation of Clinical Performance of Ponto Implantation Using a Minimally Invasive Surgical Technique-A Prospective Multicenter Study.

Objective: To investigate the clinical outcomes of bone-anchored hearing implant surgery using the MONO procedure.

Study Design: Multicenter, multinational, single-arm, prospective trial with a 12-month follow-up.

Setting: Seven European university hospitals from the United Kingdom, Sweden, Denmark, and The Netherlands.

Minimally invasive surgery as a new clinical standard for bone anchored hearing implants-real-world data from 10 years of follow-up and 228 surgeries.

Purpose: To explore the clinical practice development of different surgical techniques when installing bone-anchored hearing implants and their associated trends in outcomes.

Design: Retrospective study of 228 bone-anchored hearing implants in 200 patients, performed over a 10-year period between 2012 and 2022 in a referral hospital.

Method: Real-world data of demography, etiology, surgical setup, complications, and audiological outcomes were collected.

Health Economic Cost Analysis for Percutaneous Bone Conduction Devices: The Minimally Invasive Ponto Surgery Versus Linear Incision Technique with Tissue Preservation.

Objectives: To identify differences in mean cost per patient between the Minimally Invasive Ponto Surgery (MIPS) and the linear incision technique with tissue preservation (LITT-P).

Study Design: Health economic cost analysis.

Setting: The analysis was performed in a randomized multicenter controlled trial cohort.

Non-invasive sampling procedure revealing the molecular events at different abutments of bone-anchored hearing systems-A prospective clinical pilot study.

Purpose: To investigate the molecular activities in different compartments around the bone-anchored hearing system (BAHS) with either electropolished or machined abutments and to correlate these activities with clinical and microbiological findings.

Materials And Methods: Twelve patients received machined or electropolished abutments after implant installation of BAHS. Peri-abutment fluid and tissue were collected from baseline to 12 months.

Long-term osseointegration of laser-ablated hearing implants in sheep cranial bone.

Osseointegration, the ability for an implant to be anchored in bone tissue with direct bone-implant contact and allowing for continuous adaptive remodelling, is clinically used in different reconstructive fields, such as dentistry, orthopedics and otology. The latter uses a bone conducting sound processor connected to a skin-penetrating abutment that is mounted on a titanium implant placed in the temporal bone, thereby acting as a path for transmission of the vibrations generated by the sound processor. The success of the treatment relies on bone healing and osseointegration, which could be improved by surface modifications.

Evaluation of a New Drill System for Placement of Percutaneous Bone Conduction Devices.

The procedure for installation of a percutaneous bone-conducting device has undergone significant improvements since its introduction 40 years ago. Today, the linear incision technique with tissue preservation (LITT-P) and the minimally invasive procedure (MIPS) are the most commonly used approaches. In both these techniques, a gradual increase of the osteotomy using a three-step drilling sequence is utilized, as this approach can allow a stepwise deepening and widening of the osteotomy in the mastoid and can prevent bone overheating.

Achieving stomal continence with an ileal pouch and a percutaneous implant.

In this study, a soft-tissue-anchored, percutaneous port used as a mechanical continence-preserving valve in reservoir ileo- and urostomies was functionally and morphologically evaluated in eight dogs. During follow-up, the skin failed to attach to the implant, but the intestine inside the stoma port appeared to be attached to the mesh. After reaching adequate reservoir volume, the urostomies were rendered continent by attaching a lid to the implant.

Clinical Evaluation of a Novel Laser-Ablated Titanium Implant System for Bone Anchored Hearing Systems in a Pediatric Population and the Relationship of Resonance Frequency Analysis With Implant Survival.

Objective: To evaluate the clinical outcomes of pediatric patients implanted a novel 4.5 mm wide laser ablated titanium bone anchored implant system and to evaluate the implant stability over the first 12-month period.

Study Design: A prospective, single-subject, repeated measure, cohort study.

Multimodal Analysis of the Tissue Response to a Bone-Anchored Hearing Implant: Presentation of a Two-Year Case Report of a Patient With Recurrent Pain, Inflammation, and Infection, Including a Systematic Literature Review.

Osseointegration is a well-established concept used in applications including the percutaneous Bone-Anchored Hearing System (BAHS) and auricular rehabilitation. To date, few retrieved implants have been described. A systematic review including cases where percutaneous bone-anchored implants inserted in the temporal bone were retrieved and analyzed was performed.

Long-Term Outcomes of the Minimally Invasive Ponto Surgery vs. Linear Incision Technique With Soft Tissue Preservation for Installation of Percutaneous Bone Conduction Devices.

Comparing the surgical outcomes of the Minimally Invasive Ponto Surgery (MIPS) technique with the linear incision technique with soft tissue preservation (LITT-P) for bone conduction devices after a follow-up of 22 months. In this multicenter randomized controlled trial, there was the inclusion of 64 adult patients eligible for unilateral surgery. There was 1:1 randomization to the MIPS (test) or the LITT-P (control) group.

Psychosocial outcome measures for conductive and mixed hearing loss treatment: An overview of the relevant literature.

Objective: To identify the psychosocial assessments utilized with individuals with conductive and/or mixed hearing loss as part of a broader effort by the Auditory Rehabilitation Outcomes Network (AURONET) group to develop a core set of patient-centred outcome measures.

Design: A review of articles published between 2006 and 2016 was completed. Included studies had more than three adult participants, were available in English, and reported a psychosocial outcome from any treatment of mixed and/or conductive hearing loss.

Hearing outcome measures for conductive and mixed hearing loss treatment in adults: a scoping review.

Objective: Rehabilitation options for conductive and mixed hearing loss are continually expanding, but without standard outcome measures comparison between different treatments is difficult. To meaningfully inform clinicians and patients core outcome sets (COS), determined via a recognised methodology, are needed. Following our previous work that identified hearing, physical, economic and psychosocial as core areas of a future COS, the AURONET group reviewed hearing outcome measures used in existing literature and assigned them into different domains within the hearing core area.

In Vitro and Ex Vivo Evaluation of a Novel Guided Drill System for Bone-Anchored Hearing Implants.

Purpose: The aim of this study was to evaluate a new guided drill system (MIPS) for placement of bone-anchored hearing systems (BAHS) with respect to cutting performance, generation of heat, and distortion of the bone during drilling and compare it with a conventional drill system (Ponto). Further, the role of irrigation and drilling procedure with respect to the degree of heat generation was evaluated.

Materials And Methods: Compact artificial bone was subjected to each drill in the two systems (conventional vs guided) while measuring thrust force, torque, and temperature.

Microbiome on the Bone-Anchored Hearing System: A Prospective Study.

The bone-anchored hearing system (BAHS) has evolved to a common treatment option for various types of hearing revalidation. The BAHS consists of an implant in the skull that breeches the skin. Soft tissue reactions are a common complication associated with BAHS and are generally poorly understood.

Minimally Invasive Ponto Surgery Versus the Linear Incision Technique With Soft Tissue Preservation for Bone Conduction Hearing Implants: A Multicenter Randomized Controlled Trial.

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.

Cytokine expression profile in the bone-anchored hearing system: 12-week results from a prospective randomized, controlled study.

Objective: To study the effect of implanting the percutaneous bone-anchored hearing system (BAHS) itself and inflammation of the peri-abutment skin warrant clarification. In this study, we aimed to acquire further insight into the immune responses related to BAHS surgery and peri-implant skin inflammation.

Materials And Methods: During surgery and 12 weeks post-implantation, skin biopsies were obtained.

The clinical outcome and microbiological profile of bone-anchored hearing systems (BAHS) with different abutment topographies: a prospective pilot study.

Purpose: In this prospective clinical pilot study, abutments with different topologies (machined versus polished) were compared with respect to the clinical outcome and the microbiological profile. Furthermore, three different sampling methods (retrieval of abutment, collection of peri-abutment exudate using paper-points, and a small peri-abutment soft-tissue biopsy) were evaluated for the identification and quantification of colonising bacteria.

Methods: Twelve patients, seven with machined abutment and five with polished abutment, were included in the analysis.

The Use of Cone Beam Computed Tomography in Assessing the Insertion of Bone Conduction Hearing Implants.

Objective: This study aimed to compare postoperative cone beam CT (CBCT) imaging to implant stability quotient (ISQ) measurement and direct caliper measurements as a suitable technique to assess bone conduction hearing implant (BCHI) seating and insertion depth.

Methods: , BCHIs were completely ( = 9) and partially inserted ( = 9) in bone blocks of different densities and subsequently scanned. Scans were processed using 3DSlicer 4.

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).

Laser-Modified Surface Enhances Osseointegration and Biomechanical Anchorage of Commercially Pure Titanium Implants for Bone-Anchored Hearing Systems.

Osseointegrated implants inserted in the temporal bone are a vital component of bone-anchored hearing systems (BAHS). Despite low implant failure levels, early loading protocols and simplified procedures necessitate the application of implants which promote bone formation, bone bonding and biomechanical stability. Here, screw-shaped, commercially pure titanium implants were selectively laser ablated within the thread valley using an Nd:YAG laser to produce a microtopography with a superimposed nanotexture and a thickened surface oxide layer.

Integration between a percutaneous implant and the porcine small bowel.

Inflammatory bowel diseases, cancer or trauma may require removal of all or part of the intestines, leaving the patient with a need to wear external stoma appliances for collection of bowel contents. By connecting the small bowel to a percutaneous port, equipped with a sealing lid, a fully continent and leak proof stoma can be created without a need for permanently wearing stoma appliance. The prerequisites for a connection between a permanent, transabdominal implant and a visceral organ are largely unexplored.