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PURPOSE: Single-sided deafness (SSD) presents significant challenges for patients, including compromised sound localization, reduced speech recognition, and often, tinnitus. These issues are typically addressed using interventions such as cochlear implantation (CI) and bone conduction implant (BCI). However, evidence regarding the efficacy of BCI in reducing tinnitus in SSD patients remains limited. This study explored the ability of a novel active transcutaneous BCI (Bonebridge BCI602) to alleviate tinnitus in SSD patients. STUDY DESIGN: Prospective cohort multicenter study. SETTING: Tertiary referral hospitals. METHODS: A prospective multicenter study of 30 SSD patients was conducted. The patients were divided into two groups: those with (n = 19) and without (n = 11) tinnitus. Audiometric assessments, subjective questionnaires including the Abbreviated Profile of Hearing Aid Benefit (APHAB) and the Bern Benefit in Single-Sided Deafness (BBSS), and tinnitus evaluations with the Tinnitus Handicap Inventory (THI) and tinnitogram were conducted before and after BCI surgery. RESULTS: THI scores after surgery were significantly reduced in SSD patients with tinnitus. Subjective satisfaction improved in both the tinnitus and non-tinnitus groups; however, the former group exhibited a significantly greater improvement in the APHAB questionnaire score. According to tinnitograms, the loudness of tinnitus decreased, particularly in patients with ipsilateral tinnitus. Patients with residual hearing had greater reductions in their THI scores. However, three patients without residual hearing had a relative worsening of tinnitus after surgery. CONCLUSION: The Bonebridge BCI602 effectively reduced tinnitus in SSD patients, particularly in those with residual hearing. Subjective satisfaction improved in both the tinnitus and non-tinnitus groups. These findings demonstrate the therapeutic potential of BCI for managing SSD and associated tinnitus.

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OBJECTIVE: The purpose of this study was to review patient demographics, indications, intraoperative findings, complications/adverse events, and audiological outcomes related to the implantation of the Osia 2 device. STUDY DESIGN: Retrospective case series. SETTING: Single tertiary institutional experience. METHODS: Patients who had undergone Osia 2 implantation by the senior author were identified from 2019 to present. Information was extracted from patient charts concerning patient demographics, indications for implantation, surgical findings, audiological outcomes, and adverse events. RESULTS: Sixty patients and 67 implants were included. The median age was 51 years (R: 11-92). Fifty-five percent of patients had mixed hearing loss (HL), 30% had single-sided deafness, and 15% had conductive HL. The mean operative time was 53.9 minutes. Only 4.5% of patients required bone polishing, and 3.0% required tissue thinning. The mean pure-tone averages 4 gain from unaided conditions was 41.2 dB. Mean gain at 6 and 8 kHz from unaided conditions was 35.42 and 40.67 dB, respectively. Mean improvement in speech recognition threshold and word recognition score was significant in noise and quiet conditions. The all-cause adverse event/complication rate in our series was 10.4%. The most common complications were infections (4.5%) and poorly controlled postoperative pain (3.0%). Hematomas occurred in 1.5% of patients. Reoperation was required in 4 patients; explant in 1. CONCLUSION: Use of the Osia 2 device in our series has resulted in good hearing outcomes, particularly in terms of high frequency gain. Complication rates were low. To our knowledge, this is the largest study to date reporting on Osia 2 outcomes.

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PURPOSE: To investigate 2-year post-operative hearing performance, safety, and patient-reported outcomes of hearing-impaired adults treated with the Osia® 2 System, an active osseointegrated bone-conduction hearing implant that uses piezoelectric technology. METHODS: A prospective, multicenter, open-label, single-arm, within-subject clinical study conducted at three tertiary referral clinical centers located in Melbourne, Sydney and Hong Kong. Twenty adult recipients of the Osia 2 System were enrolled and followed up between 12 and 24 months post-implantation: 17 with mixed or conductive hearing loss and 3 with single-sided sensorineural deafness. Safety data, audiological thresholds, speech recognition thresholds in noise, and patient-reported outcomes were collected and evaluated. In addition, pre-and 6-month post-implantation data were collected retrospectively for this recipient cohort enrolled into the earlier study (ClinicalTrials.gov NCT04041700). RESULTS: Between 6- and 24-month follow-up, there was no statistically significant change in free-field hearing thresholds or speech reception thresholds in noise (p = > 0.05), indicating that aided improvements were maintained up to 24 months of follow-up. Furthermore, improvements in health-related quality of life and daily hearing ability, as well as clinical and subjective measures of hearing benefit remained stable over the 24-month period. No serious adverse events were reported during extended follow-up. CONCLUSIONS: These study results provide further evidence to support the longer term clinical safety, hearing performance, and patient-related benefits of the Osia 2 System in patients with either a conductive hearing loss, mixed hearing loss, or single-sided sensorineural deafness. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04754477. First posted: February 15, 2021.

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BACKGROUND: The active transcutaneous, partially implantable osseointegrated bone conduction system Cochlear™ Osia® (Cochlear, Sydney, Australia) has been approved for use in German-speaking countries since April 2021. The Osia is indicated for patients either having conductive (CHL) or mixed hearing loss (MHL) with an average bone conduction (BC) hearing loss of 55 dB HL or less, or having single-sided deafness (SSD). OBJECTIVES: The aim of this retrospective study was to investigate the prediction of postoperative speech recognition with Osia® and to evaluate the speech recognition of patients with MHL and in particular an aided dynamic range of less than 30 dB with Osia®. MATERIALS AND METHODS: Between 2017 and 2022, 29 adult patients were fitted with the Osia®, 10 patients (11 ears) with CHL and 19 patients (25 ears) with MHL. MHL was subdivided into two groups: MHL­I with four-frequency pure-tone average in BC (BC-4PTA) ≥ 20 dB HL and < 40 dB HL (n = 15 patients; 20 ears) vs. MHL-II with BC-4PTA ≥ 40 dB HL (n = 4 patients; 5 ears). All patients tested a bone conduction hearing device on a softband preoperatively. Speech intelligibility in quiet was assessed preoperatively using the Freiburg monosyllabic test in unaided condition, with the trial BCHD preoperatively and with Osia® postoperatively with Osia®. The maximum word recognition score (mWRS) unaided and the word recognition score (WRS) with the test system at 65 dB SPL were correlated with the postoperative WRS with Osia® at 65 dB SPL. RESULTS: Preoperative prediction of postoperative outcome with Osia® was better using the mWRS than by the WRS at 65 dB SPL with the test device on the softband. Postoperative WRS was most predictive for patients with CHL and less predictable for patients with mixed hearing loss with BC-4PTA ≥ 40 dB HL. For the test device on a softband, the achievable outcome tended to a minimum, with the mWRS tending to predict the realistically achievable outcome. CONCLUSION: Osia® can be used for the treatment of CHL and MHL within the indication limits. The average preoperative bone conduction hearing threshold also provides an approximate estimate of the postoperative WRS with Osia®, for which the most accurate prediction is obtained using the preoperative mWRS. Prediction accuracy decreases from a BC-4PTA of ≥ 40 dB HL.

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OBJECTIVE: To investigate the safety and efficacy of a novel active transcutaneous bone conduction implant (BCI) device for patients with single-sided deafness (SSD). STUDY DESIGN: Prospective cohort study. SETTING: Tertiary referral hospitals. METHODS: This prospective multicenter study was conducted at 15 institutions nationwide. Thirty adult (aged ≥19 years) SSD patients were recruited. They underwent implantation of an active transcutaneous BCI device (Bonebridge BCI602). Objective outcomes included aided pure-tone thresholds, aided speech discrimination scores (SDSs), and the Hearing in Noise Test (HINT) and sound localization test results. The Bern Benefit in Single-Sided Deafness (BBSS) questionnaire, the Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire, and the Tinnitus Handicap Inventory (THI) were used to measure subjective benefits. RESULTS: The mean aided pure-tone threshold was 34.2 (11.3), mean (SD), dB HL at 500 to 4000 Hz. The mean total BBSS score was 27.5 (13.8). All APHAB questionnaire domain scores showed significant improvements: ease of communication, 33.6 (23.2) versus 22.6 (21.3), P = .025; reverberation, 44.8 (16.6) versus 32.8 (15.9), P = .002; background noise, 55.5 (23.6) versus 35.2 (18.1), P < .001; and aversiveness, 36.7 (22.8) versus 25.8 (21.4), P = .028. Moreover, the THI scores were significantly reduced [47.4 (30.1) versus 31.1 (27.0), P = .003]. Congenital SSD was a significant factor of subjective benefit (-11.643; 95% confidence interval: -21.946 to -1.340). CONCLUSION: The BCI602 active transcutaneous BCI device can provide functional hearing gain without any adverse effects and is a feasible option for acquired SSD patients with long-term deafness.

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PURPOSE: Hearing rehabilitation through middle ear surgery can be challenging, particularly for patients with chronic otitis media, but new hearing devices offer opportunity to reach this goal. The aim was to compare hearing outcomes and quality of life in patients who were converted from a Baha Attract system to the Osia system. METHODS: Prospective observational study, in which each subject acted as their own control. Six patients who were converted from a Baha Attract to an Osia system performed audiometric and quality of life assessments with different sound processor at fitting, 3, 6 and 12 months. The speech performance in noise with the Osia system at 12 months, expressed as dB SNR, was compared to the baseline condition (Baha 5). RESULTS: The PTA4 hearing thresholds improved from 42.6 ± 11 with Baha 5 Power to 34.8 ± 13.3 with Baha 5 SuperPower and to 25.4 ± 3.5 with the Osia at 12 months, leading to a significant functional gain of 17.2 ± 10.9 dB vs Baha 5 (p < 0.02). Speech understanding in both quiet and noise was clinically improved reaching a mean SNR of less than 1 dB at 12 months with the Osia system. Quality of life outcomes improved by more than 20% at 12-month follow-up. CONCLUSION: Aided hearing thresholds and speech understanding in noise improved when patients were converted from the Baha Attract system to the Osia system. The aided hearing threshold was maintained up to 8 kHz (26 dB) with the Osia system.

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BACKGROUND: The active transcutaneous, partially implantable osseointegrated bone conduction system Cochlear™ Osia® (Cochlear, Sydney, Australia) has been approved for use in German-speaking countries since April 2021. The Osia is indicated for patients with conductive (CHL) or mixed hearing loss (MHL) with an average bone conduction (BC) hearing loss of 55 dB or less, or with single-sided deafness (SSD). OBJECTIVES: The aim of this retrospective study was to investigate the prediction of postoperative speech recognition with Osia and to evaluate the speech recognition of patients with MHL and an aided dynamic range of less than 30 dB with Osia. MATERIALS AND METHODS: Between 2017 and 2022, 29 adult patients were fitted with the Osia, 10 patients (11 ears) with CHL and 19 patients (21 ears) with MHL. MHL was subdivided into two groups: MHL­I with four-frequency pure-tone average in BC (BC-4PTA) ≥ 20 dB HL and < 40 dB HL (n = 15 patients; 20 ears) vs. MHL-II with BC-4PTA ≥ 40 dB HL (n = 4 patients; 5 ears). All patients tested a bone conduction hearing device on a softband preoperatively. Speech intelligibility in quiet was assessed preoperatively using the Freiburg monosyllabic test unaided and with the test system and postoperatively with Osia. The maximum monosyllabic score (mEV) unaided and the monosyllabic score with the test system at 65 dB SPL were correlated with the postoperative monosyllabic score with Osia at 65 dB SPL. RESULTS: Preoperative prediction of postoperative outcome with Osia was better using the mEV than the EV at 65 dB SPL with the test device on the softband. Postoperative EV was most predictive for patients with CHL and least predictive for patients with mixed hearing loss with 4PTA BC ≥ 40 dB HL. For the test device at softband, results tended to show the minimum achievable outcome and the mEV tended to predict the realistically achievable outcome. CONCLUSION: Osia can be used for the treatment of CHL and MHL within the indication limits. The average preoperative bone conduction hearing threshold also provides an approximate estimate of the postoperative EV with Osia, for which the most accurate prediction is obtained using the preoperative mEV. Prediction accuracy decreases from a BC-4PTA of ≥ 40 dB.

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Objectives: The young population requires early rehabilitation of their hearing loss for normal cognitive, auditive hence social development. All of which, in turn, may have an impact on quality of life (QoL). This study aims to evaluate QoL between two different bone conduction (BC) hearing devices: a noninvasive adhesive hearing aid (Adhear [ADH]) vs. an active transcutaneous implant (Bonebridge [BB]). Methods: This study composed of 12 BB and 15 ADH users. Pure tone as well as speech in noise and quiet measurements were evaluated and compared to the Assessment in QoL questionnaire (AQoL-6d). Results: Freefield results showed significant improvements for both devices compared to the unaided condition (p < .0001). Emphasis needs to be drawn on the different unaided level of conductive hearing loss as well as the indication range for both evaluated device groups: the ADH subjects exhibited a mean BC value of 9.50 ± 7.96 dB HL (the indication range up to 25 dB) and the BB subjects a mean of 23.33 ± 25.66 dB HL (the indication range up to 45 dB). Speech perception in quiet and in noise was significantly improved (p < .05; p < .001, respectively). QoL was significantly improved for both treatments (p < .05) but was not different among the devices, and the values were similar to their normal hearing, age, and sex-matched control group. High correlations were found between QoL utility scores and improved PTA4 in the aided condition (r 2 = .8839 and .7810 for BB and ADH, respectively). Conclusion: Our results show that both devices offer significant beneficial audiological rehabilitations with significantly increased QoL. However, the underlying condition and the unaided degree of hearing loss, hence the required higher stimulation must be the deciding factor when opting for a hearing device, and this should be independent of age. Level of evidence: 2c.

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The Bonebridge (BB) was the first active transcutaneous implantation system for bone conduction. The main indications are conductive or mixed hearing loss and single-sided deafness. Treacher-Collins syndrome (TCS) is a rare genetic disease that affects craniofacial development. The disorder results in deformations of facial structure including ear malformations, especially microtia and ear canal atresia. These patients suffer from conductive hearing loss. CT scans often show unfavorable temporal bone anatomy making placement of an implant difficult. For implantable hearing rehabilitation, patients may decide for conduction implants, such as a BAHA, a Ponto, a Vibrant Soundbridge, or a Bonebridge. In this case report, we present 2 patients with TCS implanted with the Bonebridge system, their audiological results, and quality of life.

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Active transcutaneous bone conduction devices are a type of bone conduction device developed to keep the skin intact and provide direct bone conduction stimulation. The Bone Conduction Implant (BCI) is such a device and has been implanted in 16 patients. The objective of this paper is to give a broad overview of the BCI development to the final results of 13 patients at 5-year follow-up. Follow-up of these patients included audiological performance investigations, questionnaires, as well as safety evaluation and objective functionality testing of the device. Among those audiological measurements were sound field warble tone thresholds, speech recognition threshold (SRT), speech recognition score (SRS) and signal to noise ratio threshold (SNR-threshold). The accumulated implant time for all 16 patients was 113 years in February 2022. During this time, no serious adverse events have occurred. The functional improvement for the 13 patients reported in this paper was on average 29.5 dB (average over 0.5, 1, 2 and 4 kHz), while the corresponding effective gain was -12.4 dB. The SRT improvement was 24.5 dB and the SRS improvement was 38.1%, while the aided SNR-threshold was on average -6.4 dB. It was found that the BCI can give effective and safe hearing rehabilitation for patients with conductive and mild-to-moderate mixed hearing loss.

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PURPOSE: The study aimed to evaluate audiological benefits, quality of hearing and safety of two Bonebridge generation: BCI601 and BCI602 (MED-EL, Innsbruck, Austria) in children. METHODS: Twelve children were implanted: five BCI601 and seven BCI602 comprising of ten conductive hearing loss, and two single sided deaf SSD subjects. Audiological outcomes tested were sound field audiometry, functional gain, speech recognition threshold (SRT50), speech recognition in noise (SPRINT) and localisation abilities. Subjective measures were Speech, Spatial and Qualities of Hearing Scale (SSQ12). RESULTS: The mean FG with the BCI601 was 25.0 dB and with the BCI602 28.0 dB. The benefit in SRT50 was 23.2 dB and 33.8 dB, respectively. The mean benefit in SPRINT was 15% and 6.7% and the localisation ability improved from 33.3° to 16° and from 26.2° to 17.6°, respectively. The two SSD subjects reported a FG of 17 dB, a benefit in SRT50 of 22.5 and a benefit in SPRINT of 20%. Subjective outcomes improved significantly and even exceeded the values of their age-and sex matched normal hearing peers. One revision was reported: a retroauricular emphysema above the implant occurred 12 months post-OP, it was resolved operatively with the implant still being functional. CONCLUSION: The pediatric cohort reports significant audiological benefit, even exceeding that of the age- and sex matched control. The combination of the high safety and audiological benefit makes the Bonebridge a comfortable and effective option in hearing rehabilitation in children.

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Objective: The aim was to quantify the effect of the experimental active transcutaneous Bone Conduction Implant (BCI) on spatial release from masking (SRM) in subjects with bilateral or unilateral conductive and mixed hearing loss.Design: Measurements were performed in a sound booth with five loudspeakers at 0°, +/-30° and +/-150° azimuth. Target speech was presented frontally, and interfering speech from either the front (co-located) or surrounding (separated) loudspeakers. SRM was calculated as the difference between the separated and the co-located speech recognition threshold (SRT).Study Sample: Twelve patients (aged 22-76 years) unilaterally implanted with the BCI were included.Results: A positive SRM, reflecting a benefit of spatially separating interferers from target speech, existed for all subjects in unaided condition, and for nine subjects (75%) in aided condition. Aided SRM was lower compared to unaided in nine of the subjects. There was no difference in SRM between patients with bilateral and unilateral hearing loss. In aided situation, SRT improved only for patients with bilateral hearing loss.Conclusions: The BCI fitted unilaterally in patients with bilateral or unilateral conductive/mixed hearing loss seems to reduce SRM. However, data indicates that SRT is improved or maintained for patients with bilateral and unilateral hearing loss, respectively.

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Objective: The objective of this study is to evaluate its safety and effectiveness of the bone conduction implant (BCI) having an implanted transducer and to review similar bone conduction devices.Design: This is a consecutive prospective case series study where the patients were evaluated after 1, 3, 6 and 12 months. Outcome measures were focussed on intraoperative and postoperative safety, the effectiveness of the device in terms of audiological performance and patient's experience.Study sample: Sixteen patients with average age of 40.2 (range 18-74) years have been included. Thirteen patients were operated in Gothenburg and three in Stockholm.Results: It was found that the procedure for installing the BCI is safe and the transmission condition was stable over the follow-up time. No serious adverse events or severe adverse device effects occurred. The hearing sensitivity, speech in noise and the self-assessment as compared with the unaided condition improved significantly with the BCI. These patients also performed similar or better than with a conventional bone conduction reference device on a softband.Conclusions: In summary, it was found that the BCI can provide a safe and effective hearing rehabilitation alternative for patients with mild-to-moderate conductive or mixed hearing impairments.

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Combined hearing loss is an essential indication for implantable hearing systems. Depending on the bone conduction threshold, various options are available. Patients with mild sensorineural deafness usually benefit from transcutaneous bone conduction implants (BCI), while percutaneous BCI systems are recommended also for moderate hearing loss. For combined hearing losses with moderate and high-grade cochlear hearing loss, active middle ear implants are recommended. For patients with incompatibilities or middle ear surgery, implants are a valuable and proven addition to the therapeutic options.

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OBJECTIVE: To investigate audiological and quality of life outcomes for a new active transcutaneous device, called the bone conduction implant (BCI), where the transducer is implanted under intact skin. DESIGN: A clinical study with sound field audiometry and questionnaires at six-month follow-up was conducted with a bone-anchored hearing aid on a softband as reference device. STUDY SAMPLE: Six patients (age 18-67 years) with mild-to-moderate conductive or mixed hearing loss. RESULTS: The surgical procedure was found uneventful with no adverse events. The first hypothesis that BCI had a statistically significant improvement over the unaided condition was proven by a pure-tone-average improvement of 31.0 dB, a speech recognition threshold improvement in quiet (27.0 dB), and a speech recognition score improvement in noise (51.2 %). At speech levels, the signal-to-noise ratio threshold for BCI was - 5.5 dB. All BCI results were better than, or similar to the reference device results, and the APHAB and GBI questionnaires scores showed statistically significant improvements versus the unaided situation, supporting the second and third hypotheses. CONCLUSIONS: The BCI provides significant hearing rehabilitation for patients with mild-to-moderate conductive or mixed hearing impairments, and can be easily and safely implanted under intact skin.

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