The Bonebridge Bone Conduction Hearing Implant: indication criteria, surgery and a systematic review of the literature.

EE83 Cost-Effectiveness Analysis of an Active Transcutaneous Bone Conduction Implant for Patients With Conductive or Mixed Hearing Loss or Single-Sided Deafness in Turkey

Confirm the safety and performance of the first partially implantable active transcutaneous Bone Conduction Implant (tBCI) in patients who have been implanted for a minimum of 5 years before 2023. Otolaryngology departments of 4 German and Austrian hospitals. Retrospective, multicenter, longitudinal, open-label case series study. Patients: 186 ears treated for conductive and mixed hearing loss (CMHL), or single-sided deafness (SSD) implanted for 5 years (151 aged 18y or older, 35 aged 5 to 17y) at the time of implantation. Implantation of the Bonebridge (BB) BCI 601, a partially implantable active transcutaneous Bone Conduction Implant (tBCI). Patients' audiometric pure-tone average (PTA 4 ) (0.5, 1, 2, 4 kHz) thresholds (bone conduction, sound field) and speech perception (word recognition scores) were retrospectively collected up to 10 years 10 months postoperatively. Complications were recorded with focus on revision surgery and explantations. Subgroups were adults and children. Safety was established by stable bone conduction (BC) thresholds 5 years after implantation or later with mean paired differences of -5.33 dB for adults and -8.05 dB for children and underscored by a low number of technical failures and high survival rates 10 years after implantation. Paired mean sound field PTA4 thresholds and word recognition scores significantly improved as tested by post hoc analysis 5 years or later after implantation, with functional gains for CMHL of 23.44 dB (adults), 27.69 dB (children), and word recognition scores of 58.22% (adults), 80.00% (children). Furthermore, mean sound field PTA 4 thresholds and word recognition scores remain significantly improved over time at 36.37 dB HL and 68.75% 5 years or later after implantation as tested with linear mixed-effects model. The findings of this study demonstrate that this tBCI remains safe and effective for up to 10 years.

New Bone-Anchored Amplification Options for Children

Objective: Bone conduction implants (BCI) are medical devices for conductive and mixed hearing losses as well as for single side sensorineural deafness (SSD). All direct-drive BCI transmit vibrations directly to the skull bone and can be divided into percutaneous and active transcutaneous devices. Method: We report a case series of 10 patients, suffered from mixed or conductive hearing loss, submitted to Bonebridge implantation. Audiological evaluation was conducted at six months to observe the functional impact of this device. Patients were asked to answer the Glasgow Benefit Inventory (GBI), a retrospective questionnaire, to measure the effect of the surgical intervention on the health-related quality of life. Results: The functional gain was found to range from 25 dB to 40 dB. Speech perception in noise improves in all patients and no post-operative complications were observed. GBI questionnaire has reflected high device satisfaction rate. Conclusion: Active transcutaneous BCI represent an effective and safety solution for people that cannot have adequate benefit from conventional hearing aids, to restore good audiological performance and life satisfaction.

PMD66 - HEARING RESTORATION, QUALITY OF LIFE, AND SAFETY OUTCOMES IN BONE-CONDUCTION DEVICES FOR PATIENTS WITH CONDUCTIVE OR MIXED HEARING LOSS OR SINGLE-SIDE DEAFNESS

Bone Anchored Hearing Aid (BAHA) is a small vibrator that can be reversibly attached to a Titanium (Ti) screw and implanted behind the ear. It uses the bone conduction channel to activate the cochleae by converting sound into the vibration of the screw. The two main indications are conductive hearing loss and unilateral deafness when using traditional hearing aids is not possible, as a rehabilitative or mixed hearing loss with a moderate perceptual component. For patients with canal atresia, Single-sided Deafness (SSD), and chronically discharged ears despite treatment, the BAHA implant is an option. Combination hearing loss is a crucial indicator for implanted hearing implants. Various options are accessible based on the bone conduction threshold. Patients with modest sensorineural impairment usually benefit from transcutaneous Bone Conduction Implants (BCI), while those with intermediate hearing loss may also benefit from percutaneous BCI devices. For combined, active middle ear implants are advised for hearing deficits with moderate and severe cochlear hearing loss. For individuals who need middle ear surgery or who are incompatible with other options for therapy, implants are a helpful and successful addition. Skin-drive Bone Conduction Devices (BCDs) are BCDs that vibrate the bone via the skin can also be separated into passive subcutaneous devices and traditional devices that are coupled, for instance, with soft bands with implanted magnets. BCDs that directly stimulate the bone, percutaneous devices, and dynamic transcutaneous devices are examples of direct-drive devices. The latter kind of apparatus uses embedded transducers to stimulate bone effectively via healthy skin. The BAHA, also known as the percutaneous direct-drive device (BCD), now rules the market. More direct-drive and skin-drive transcutaneous solutions are now being studied, partly due to problems with the transdermal implant and partly for aesthetic reasons.

To compare contralateral to ipsilateral stimulation with percutaneous and transcutaneous bone conduction implants. Bone conduction implants (BCIs) effectively treat conductive and mixed hearing losses. In some cases, such as in single-sided deafness, the BCI is implanted contralateral to the remaining healthy ear in an attempt to restore some of the benefits provided by binaural hearing. While the benefit of contralateral stimulation has been shown in at least some patients, it is not clear what cues or mechanisms contribute to this function. Previous studies have investigated the motion of the ossicular chain, skull, and round window in response to bone vibration. Here, we extend those reports by reporting simultaneous measurements of cochlear promontory velocity and intracochlear pressures during bone conduction stimulation with two common BCI attachments, and directly compare ipsilateral to contralateral stimulation. Fresh-frozen whole human heads were prepared bilaterally with mastoidectomies. Intracochlear pressure (PIC) in the scala vestibuli (PSV) and tympani (PST) was measured with fiber optic pressure probes concurrently with cochlear promontory velocity (VProm) via laser Doppler vibrometry during stimulation provided with a closed-field loudspeaker or a BCI. Stimuli were pure tones between 120 and 10,240 Hz, and response magnitudes and phases for PIC and VProm were measured for air and bone conducted sound presentation. Contralateral stimulation produced lower response magnitudes and longer delays than ipsilateral in all measures, particularly for high-frequency stimulation. Contralateral response magnitudes were lower than ipsilateral response magnitudes by up to 10 to 15 dB above ~2 kHz for a skin-penetrating abutment, which increased to 25 to 30 dB and extended to lower frequencies when applied with a transcutaneous (skin drive) attachment. Transcranial attenuation and delay suggest that ipsilateral stimulation will be dominant for frequencies over ~1 kHz, and that complex phase interactions will occur during bilateral or bimodal stimulation. These effects indicate a mechanism by which bilateral users could gain some bilateral advantage.

The transcutaneous bone conduction implant (BCI) is compared with bone-anchored hearing aids (BAHAs) under the hypothesis that the BCI can give similar rehabilitation from an audiological as well as patient-related point of view. Patients suffering from conductive and mixed hearing losses can often benefit more from rehabilitation using bone conduction devices (BCDs) rather than conventional air conduction devices. The most widely used BCD is the percutaneous BAHA, with a permanent skin-penetrating abutment. To overcome issues related to percutaneous BCDs, the trend today is to develop transcutaneous devices, with intact skin. The BCI is an active transcutaneous device currently in a clinical trial phase. A potential limitation of active transcutaneous devices is the loss of power in the induction link over the skin. To address this issue, countermeasures are taken in the design of the BCI, which is therefore expected to be as effective as percutaneous BCDs. An early observational study with a matched-pair design was performed to compare BCI and BAHA groups of patients over several audiometric measurements, including speech audiometry and warble tones thresholds with and without the device. Additionally, questionnaires were used to assess the general health condition, benefit, and satisfaction level of patients. No statistically significant difference was detected in any of the audiological measurements. The outcome of patient-related measurements was slightly superior for BCI in all subscales. Results confirm the initial hypothesis of the study: the BCI seems to be capable of providing as good rehabilitation as percutaneous devices for indicated patients.

To describe the early surgical and audiometric outcomes in pediatric patients implanted with a new active transcutaneous bone conduction implant system. Retrospective case review. Tertiary pediatric hospital. Pediatric patients (18 or younger) with conductive or mixed hearing loss that completed postoperative aided testing following implantation with the Cochlear Osia system from December 2019 to December 2020. Rehabilitative. Preoperative air conduction (AC), preoperative bone conduction (BC), and postoperative aided thresholds were compared. Pure-tone averages (PTA), air-bone gap (ABG), and functional gain were calculated. Surgical complications and patient satisfaction were summarized from the chart review. Sixteen patients (20 implants) met the inclusion criteria. The average age at the time of implantation was 12.9 ± 2.4 years. The preoperative AC and BC thresholds were 64.4 dB (±11.9 dB) and 7.9 dB (±4.90 dB), respectively, with an average ABG of 56.5 dB (±12.8 dB). The average postoperative aided threshold was 21.2 dB (± 4.25 dB) with a mean functional gain of 43.1 dB (±10.2 dB). One patient developed seroma postoperatively, which was treated conservatively. No other complications were reported over a mean follow-up time of 7.1 ± 4 months. For 13 patients with previous passive bone conduction implants or devices, the Osia system was universally favored. The new active transcutaneous bone conduction system showed favorable early clinical and audiometric outcomes. Repeated processor connectivity issues represent a potential area for future device development. This is the largest pediatric case series to date.Level of Evidence: Level 4-Retrospective Review.

Background: To assess and compare binaural benefits and subjective satisfaction of active bone conduction implant (BCI) in patients with bilateral conductive or mixed hearing loss fitted with bilateral BCI and patients with monaural conductive hearing loss fitted with monaural BCI. Methods: ITA Matrix test was performed both on patients affected by bilateral conductive or mixed hearing loss fitted with monaural bone conduction hearing implant (Bonebridge, Med-El) before and after implantation of contralateral bone conduction hearing implant and on patients with monaural conductive or mixed hearing loss before and after implantation of monaural BCI. The Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire was administered to both groups of subjects and the results were compared with each other. Results: Patients of group 1 reported a difference of 4.66 dB in the summation setting compared to 0.79 dB of group 2 (p < 0.05). In the squelch setting, group 1 showed a difference of 2.42 dB compared to 1.53 dB of group 2 (p = 0.85). In the head shadow setting, patients of group 1 reported a difference of 7.5 dB, compared to 4.61 dB of group 2 (p = 0.34). As for the APHAB questionnaire, group 1 reported a mean global score difference of 11.10% while group 2 showed a difference of −4.00%. Conclusions: Bilateral BCI in patients affected by bilateral conductive or mixed hearing loss might show more advantages in terms of sound localisation, speech perception in noise and subjective satisfaction if compared to unilateral BCI fitting in patients affected by unilateral conductive hearing impairment. This may be explained by the different individual transcranial attenuation of each subject, which might lead to different outcomes in terms of binaural hearing achievement. On the other hand, patients with unilateral conductive or mixed hearing loss fitted with monaural BCI achieved good results in terms of binaural hearing and for this reason, there is no absolute contraindication to implantation in those patients.

To present surgical and audiometric outcomes of patients implanted with an active transcutaneous bone conduction implant following the novel middle fossa surgical approach with self-drilling screws. Retrospective review. Tertiary care center. Thirty-seven adults with either conductive or mixed hearing loss that met indications for an active transcutaneous bone conduction implant were consecutively implanted from April, 2013 to May, 2018. Unilateral middle fossa implantation of an active transcutaneous bone conduction implant. Patient charts were reviewed for surgical outcomes and complications over the 6-year period. Preoperative air conduction, preoperative bone conduction, and 3-month postoperative aided thresholds were recorded. Speech perception was assessed using CNC words and AzBio sentences. Pure-tone averages (PTAs; measured at 0.5, 1.0, 2.0 and 3.0 kHz), air-bone gap, and functional gain were calculated. Mean air conduction and bone conduction PTAs (±standard deviation) of the implanted ear were 66.8 dB (±14.9 dB) and 21.9 dB (±14.0 dB), respectively. Mean aided PTA was 26.5 dB (± 8.5 dB). The average functional gain was 40.3 dB (±19.0 dB). Favorable speech perception outcomes were observed. No complications or instances of revision surgery were reported, with a mean follow-up time of 32 months (range, 9-71 mo). This is the first paper to describe outcomes of patients implanted with an active transcutaneous bone conduction implant via the middle fossa with self-drilling screws. Favorable surgical outcomes were observed with a follow-up of up to 6 years.

The objective of this study is to evaluate the safety and efficacy of a new transcutaneous bone-conduction implant (BCI BB) in patients with conductive and mixed hearing loss or with single-sided deafness (SSD), 1year after surgical implantation. The study design is multicentric prospective, intra-subject measurements. Each subject is his/her own control. The setting is nine university hospitals: 7 French and 2 Belgian. Sixteen subjects with conductive or mixed hearing loss with bone-conduction hearing thresholds under the upper limit of 45dB HL for each frequency from 500 to 4000Hz, and 12 subjects with SSD (contralateral hearing within normal range) were enrolled in the study. All subjects were older than 18years. The intervention is rehabilitative. The main outcome measure is the evaluation of skin safety, audiological measurements, benefit, and satisfaction questionnaires with a 1-year follow up. Skin safety was rated as good or very good. For the mixed or conductive hearing loss groups, the average functional gain (at 500Hz, 1, 2, 4kHz) was 26.1dB HL (SD 13.7), and mean percentage of speech recognition in quiet at 65dB was 95% (vs 74% unaided). In 5/6 SSD subjects, values of SRT in noise were lower with BB. Questionnaires revealed patient benefit and satisfaction. The transcutaneous BCI is very well tolerated at 1-year follow up, improves audiometric thresholds and intelligibility for speech in quiet and noise, and gives satisfaction to both patients with mixed and conductive hearing loss and patients with SSD.

To determine the therapeutic success and safety of an active transcutaneous bone conduction implant (tBCI) in adult patients with conductive or mixed hearing loss. Retrospective case review. Five university hospitals in Frankfurt, Hannover, Dresden, Würzburg, and Vienna. Data were analyzed from 61 patients (31 women, 30 men) with a mean age of 50 years (min. 26, max. 80). Forty patients had mixed, and 21 conductive hearing loss. Typical etiologies were history of otitis media (n = 20) and cholesteatoma (n = 17). Implantation of the active tBCI. Data were analyzed for the following time points: up to 6 months postoperatively ("short-term"), 6 to 37 months postoperatively ("long-term"), and the last available measurement per patient ("most recent"). Pure-tone audiometry (air and bone conduction, AC and BC) and sound field thresholds with warble tones (WT), word recognition scores with Freiburger monosyllables (WRS), as well as speech reception thresholds (SRT) using the Oldenburg sentence test (OLSA) in quiet (SRT) and in noise (signal-to-noise ratio, SNR) were collected. No significant changes in air- and bone-conduction thresholds were observed after implantation. A mean WRS improvement of 54% using the active tBCI was shown at the short-term assessment, i.e., a mean score of 79% compared with 25% in the unaided condition. Results remained stable, with a mean score of 75% at the long-term assessment. SRT in noise improved by 3.6 dB SNR in the implanted ear at the short-term assessment. Overall six adverse events and four serious adverse events were reported, resulting in a rate of 9.84 and 6.56%, respectively. The tBCI clearly improves speech intelligibility in patients with conductive or mixed hearing loss, showing stable results up to 1 year post-implantation.

Retrosigmoid implantation of an active bone conduction stimulator in a patient with chronic otitis media

The number of potential options for rehabilitation of patients with conductive or mixed hearing loss is continually expanding. To be able to inform patients and other stakeholders, there is a need to identify and develop patient-centred outcomes for treatment of hearing loss. To identify outcome measures in the physical core area used when reporting the outcome after treatment of conductive and mixed hearing loss in adult patients. Systematic review. Systematic review of the literature related to reported physical outcome measures after treatment of mixed or conductive hearing loss without restrictions regarding type of intervention, treatment or device. Any measure reporting the physical outcome after treatment or intervention of mixed or conductive hearing loss was sought and categorised. The physical outcome measures that had been extracted were then grouped into domains. The literature search resulted in the identification of 1434 studies, of which 153 were selected for inclusion in the review. The majority (57%) of papers reported results from middle ear surgery, with the remainder reporting results from either bone conduction hearing devices or middle ear implants. Outcomes related to complications were categorised into 17 domains, whereas outcomes related to treatment success was categorised into 22 domains. The importance of these domains to patients and other stakeholders needs to be further explored in order to establish which of these domains are most relevant to interventions for conductive or mixed hearing loss. This will allow us to then assess which outcome measures are most suitable for inclusion in the core set.