Early Osia® 2 bone conduction hearing implant experience: Nationwide controlled-market release data and single-center outcomes.

PURPOSE: Bone conduction hearing devices are a well-established treatment option for conductive or mixed hearing losses as well as single-sided deafness. The Osia® 2 System is an active osseointegrated device where a surgically implanted titanium fixture supports a newly developed piezoelectric actuator that is placed under the skin. METHODS: Nationwide data collected during a controlled-market release (CMR) of the Cochlear™ Osia® 2 System as well as outcomes at single, tertiary-level private practice Otology/Neurotology center were retrospectively reviewed. Key learnings from surgeons and audiologists are discussed. RESULTS: During the CMR period, 23 surgeons performed 44 operations on 43 recipients. The mean age of recipients was 44 years and mean surgery duration was 52 min. The most commonly used incision was postauricular but anterior to the device (78%). Five complications were observed during the CMR, none of which were device related. Twenty-one audiologists performed 33 Osia® 2 activations during the CMR. The mean age of this group was 47 years, and the mean duration of each activation appointment was 55 min. Single-center data at the authors' institution demonstrated an average additional PTA4 gain with the Osia® 2 patients of 9.6 dB compared to Baha Attract and 10.2 dB compared to Baha Connect. CONCLUSION: The Cochlear™ Osia® 2 System represents a significant advance in auditory osseointegrated implant technology. Digital piezoelectric stimulation delivers high power outputs, improves high frequency gain for optimal speech perception, and maintains safety while providing excellent patient satisfaction.

A comparison study of audiological outcome and compliance of bone conduction implantable hearing implants.

PURPOSE: The present study aimed to evaluate and compare the outcome of different bone conduction hearing implants (BCHIs) in subjects with mixed hearing loss (MHL) and single-sided deafness (SSD) in terms of audiometric results and compliance. METHODS: Twenty-one subjects with MHL and 18 subjects with SSD undergoing implantation of Baha connect, Baha attract, or Bonebridge were enrolled. Functional gain, effective gain, and usage rate of BCHIs were retrospectively reviewed. RESULTS: As for MHL, the functional gain of three devices was not significantly different (p = 0.477), while the effective gain of Bonebridge was higher (- 8.8 [- 15.0, - 3.5] dB) than that of Baha connect (- 20.0 [- 26.3, - 11.3] dB, p = 0.037), especially at 0.5 kHz (p = 0.010) and 1 kHz (p = 0.014). In SSD subjects, the effective gain of Bonebridge was significantly higher than that of Baha attract (- 11.3 [- 15.0, - 7.5] vs - 21.3 [- 21.3, - 16.3] dB, p = 0.012), while the functional gain of Bonebridge and Baha attract was not different. The constant usage rate of BCHIs tends to be higher in MHL subjects [17/21 (82%)] than that in SSD subjects [10/18 (56%)]. In SSD subjects, the constant user group showed higher functional gain than the non-constant user group, with a significant difference at 3 kHz (35.0 [33.8, 45.0] vs 17.5 [10.0, 27.5] dB, p = 0.006). CONCLUSION: Bonebridge shows a higher effective gain than Baha connect in the MHL group and Baha attract in the SSD group. The usage rate of BCHIs is lower in SSD than that in MHL. In SSD subjects, the constant user group tended to show higher functional gain than the non-constant user group. Irrespective of the device type, the tendency of higher functional gain of BCHIs, especially at mid frequencies, may potentially lead to yield good compliance in SSD, mandating a meticulous fitting strategy ensuring a sufficient mid-frequency functional gain in SSD.

Simultaneous auricular reconstruction and transcutaneous bone conduction device implantation in patients with microtia.

BACKGROUND/PURPOSE: The Bonebridge (BB) is a newly designed transcutaneous bone conduction hearing implant. We describe, for the first time, simultaneous BB implantation and different surgical techniques of auricular reconstruction for microtia patients with aural atresia/stenosis. METHODS: Ten patients with unilateral or bilateral microtia underwent BB implantation combined simultaneously with either total auricular reconstruction using bespoke hand-carved Medpor framework or second stage auricular projection using autologous costal cartilage framework. Auditory aided and unaided sound fields were evaluated using (1) a pure-tone average (PTA4), (2) a speech reception threshold (SRT), and (3) a Speech Discrimination Score (SDS) at a sound level of 65 dB SPL. RESULTS: All patients and their families were satisfied with the aesthetic outcome of their constructed ears with no requests for further revision. No major complications were encountered. One patient developed minor partial skin graft epidermolysis that healed uneventfully, and another patient had a three month period of auditory acclimatization to the BB device that resolved. Postoperatively, the mean aided PTA4 decreased by 35.35 dB, while the SRT was 54.5 dB HL unaided and 28 dB HL with use of a BB sound processor. The SDS increased by 16.4%-65 dB SPL. CONCLUSION: Simultaneous BB implantation during either total auricular reconstruction or framework projection for microtia patients who have aural atresia/stenosis is feasible and safe. This approach reduces operative stages, thereby minimizing schooling/occupational disruption and time to total microtia reconstruction and auditory rehabilitation.

Retrosigmoidal placement of an active transcutaneous bone conduction implant: surgical and audiological perspectives in a multicentre study.

INTRODUCTION: The retrosigmoidal (RS) placement of the Bonebridge system (BB) has been advocated for cases of unfavourable anatomical or clinical conditions which contraindicate transmastoid-presigmoidal positioning. However, these disadvantageous conditions, combined with the considerable dimensions of the implant, may represent a challenge, especially for surgeons with no skull base experience. Moreover, the literature reports only limited experience concerning RS implantation of the BB system. METHODS: A multicentre, retrospective study was conducted to analyse the surgical and functional outcomes of a wide population of patients undergoing RS placement of the BB system by means of a surgical technique specifically developed to overcome the intraoperative issues related to this surgery. Twenty patients with conductive or mixed hearing loss and single sided deafness were submitted to RS implantation of the BB system. RESULTS: Audiological assessment concerning the measurement of the functional and effective gain by pure-tone audiometry (28 dB HL and -12.25 dB HL, respectively) and speech audiometry (24.7 dB HL and -21 dB HL, respectively) was conducted. A high overall subjective improvement of quality of life was recorded with the Glasgow Benefit Inventory questionnaire. No major complications, such as device extrusions or other conditions requiring revision surgery, were reported during the follow-up period (median: 42 months). CONCLUSIONS: In our study, which has one of the largest cohort of patients reported in the literature, RS placement of the BB system was safe and effective. Our functional results showed comparable hearing outcomes with presigmoidal placement. The effective gain, rarely investigated in this field, may be the object of further research to improve our understanding of bone conduction mechanisms exploited by bone conduction hearing implants.

Clinical performance of the Osia™ system, a new active osseointegrated implant system. Results from a prospective clinical investigation.

Background: Bone-conduction hearing implants are standard of care devices.Aims/Objectives: Evaluation of a new active magnetic bone-conduction hearing implant: Cochlear Osia™ system.Material and methods: This device uses a transcutaneous connection between an external sound-processor and an osseointegrated implant that generates vibrations using a piezoelectricity-based internal bone-conduction system. Nine patients with conductive-hearing loss were implanted. Surgical efficacy, hearing performance and quality-of-life were evaluated. Hearing performance in quiet and in noise was compared with unaided hearing and hearing with the Baha 5 Power® Sound Processor on a softband.Results: Surgery and healing were uneventful. Statistically significant improvements in audibility, speech-understanding, speech-recognition and quality-of-sound in noise and quiet were found for the Osia™ compared to preoperative unaided hearing and aided hearing with the Baha 5 Power® Sound Processor on a softband. The active vibration system provided improvement at low and high frequencies. At 6 months postoperatively, all patients continue to use the device.Conclusions and significance: The Osia™ is safe and effective, improving speech-recognition in quiet and in noise, at low and high frequencies, thus delivering better quality-of-hearing than passive devices.

Audiological outcomes in patients with congenital aural atresia implanted with transcutaneous active bone conduction hearing implant.

OBJECTIVES: The objective of this study is to evaluate the safety and efficacy of the transcutaneous Bone Conduction Implant, the Bonebridge, in patients with congenital aural atresia. METHODS: Audiometry, speech recognition test and free field audiometry were performed. Word recognition scores and speech perception was evaluated using Spanish phonetically-balanced disyllables word list. RESULTS: Fourteen subjects were implanted with the Bonebridge (seven bilateral placements). The study cohort comprised seven males and seven females aged from 3 to 17 years (mean age 9.76yrs). All patients accepted and benefited from the implanted Bonebridge system. The pre-operative PTA4 was 66.4 dB (64.2-68.6, 95-%CI) and improved after activation to 19.2 dB (16.9-21.5, 95%CI), resulting in a mean functional gain of 47,2 dB. Regarding speech discrimination, the pre-operative outcomes of the disyllabic measurements were 34.3% and for monosyllables 27.4%. Following activation the speech discrimination improved to 98.6% and 97.9%, respectively. No infections or adverse device related effects occurred in patient group. CONCLUSION: We have concluded that the Bonebridge implant is an innovative solution for patients with conductive or mixed hearing loss and unilateral loss suffering from congenital atresia. Different surgical techniques may be used for implant placement, based on the patient's anatomy. Studies show improved functional gain, better speech perception, and lower rates of percutaneous complications associated with this implant.

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.

Can the Hydroxyapatite-Coated Skin-Penetrating Abutment for Bone Conduction Hearing Implants Integrate with the Surrounding Skin?

INTRODUCTION: Percutaneous implants, such as bone conduction hearing implants, suffer from complications that include inflammation of the surrounding skin. A sealed skin-abutment interface can prevent the ingress of bacteria, which should reduce the occurrence of peri-abutment dermatitis. It was hypothesized that a hydroxyapatite (HA)-coated abutment in conjunction with soft tissue preservation surgery should enable integration with the adjacent skin. Previous research has confirmed that integration is never achieved with as-machined titanium abutments. Here, we investigate, in vivo, if skin integration is achievable in patients using a HA-coated abutment. MATERIALS AND METHODS: One titanium abutment (control) and one HA-coated abutment (case) together with the surrounding skin were surgically retrieved from two patients who had a medical indication for this procedure. Histological sections of the skin were investigated using light microscopy. The abutment was qualitatively analyzed using scanning electron microscopy. RESULTS: The titanium abutment only had a partial and thin layer of attached amorphous biological material. The HA-coated abutment was almost fully covered by a pronounced thick layer of organized skin, composed of different interconnected structural layers. CONCLUSION: Proof-of-principle evidence that the HA-coated abutment can achieve integration with the surrounding skin was presented for the first time.