Binaural hearing in monaural conductive or mixed hearing loss fitted with unilateral Bonebridge.

Objective: To determine the benefits of binaural hearing rehabilitation in patients with monaural conductive or mixed hearing loss treated with a unilateral bone conduction implant (BCI). Methods: This monocentric study includes 7 patients with monaural conductive or mixed hearing loss who underwent surgical implantation of a unilateral BCI (Bonebridge, Med-El). An ITA Matrix test was performed by each patient included in the study - without and with the BCI and in three different settings - to determine the summation effect, squelch effect and head shadow effect. Subjective hearing benefits were assessed using the Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire. Results: The difference in signal to noise ratio of patients without and with BCI was 0.79 dB in the summation setting (p < 0.05), 4.62 dB in the head shadow setting (p < 0.05) and 1.53 dB (p = 0.063) in the squelch setting. The APHAB questionnaire revealed a subjective discomfort in the presence of unexpected sounds in patients using a unilateral BCI (aversiveness score) compared to the same environmental situations without BCI, with a mean discomfort score of 69.00% (SD ± 21.24%) with monaural BCI versus 25.67% (SD ± 16.70%) without BCI (difference: -43.33%, p < 0.05). In terms of global score, patients wearing a unilateral Bonebridge implant did not show any significant differences compared to those without hearing aid (difference: -4.00%, p = 0.310). Conclusions: Our study shows that the use of a unilateral BCI in patients affected by monaural conductive or mixed hearing loss can improve speech perception under noise conditions due to the summation effect and to the decrease of the head shadow effect. However, since monaural BCIs might lead to discomfort under noise conditions in some subjects, a pre-operative assessment of the possible individual benefit of a monaural BCI should be carried out in patients affected by unilateral conductive or mixed hearing loss in order to investigate the possible additional effect of the fitting of hearing aids.

Spatial Release From Masking With Bilateral Bone Conduction Stimulation at Mastoid for Normal Hearing Subjects.

This study investigates the effect of spatial release from masking (SRM) in bilateral bone conduction (BC) stimulation at the mastoid. Nine adults with normal hearing were tested to determine SRM based on speech recognition thresholds (SRTs) in simulated spatial configurations ranging from 0 to 180 degrees. These configurations were based on nonindividualized head-related transfer functions. The participants were subjected to sound stimulation through either air conduction (AC) via headphones or BC. The results indicated that both the angular separation between the target and the masker, and the modality of sound stimulation, significantly influenced speech recognition performance. As the angular separation between the target and the masker increased up to 150°, both BC and AC SRTs decreased, indicating improved performance. However, performance slightly deteriorated when the angular separation exceeded 150°. For spatial separations less than 75°, BC stimulation provided greater spatial benefits than AC, although this difference was not statistically significant. For separations greater than 75°, AC stimulation offered significantly more spatial benefits than BC. When speech and noise originated from the same side of the head, the "better ear effect" did not significantly contribute to SRM. However, when speech and noise were located on opposite sides of the head, this effect became dominant in SRM.

Evaluation of the Baha SoundArc in children.

OBJECTIVE: The Baha SoundArc coupling system has been developed as a non-surgical coupling of a Baha sound processor to the skull allowing the transfer of vibrational energy to the cochlear partition via bone conduction pathways. Today, there are several alternatives to this non-surgical approach as the Baha headband/test band, or the Baha Softband, or adhesive patches. Each of these current options have benefits and liabilities. The aim of the study was to evaluate pediatric experience and performance when using two non-surgical options, the Baha SoundArc compared to the Baha Softband. METHODS: Twenty-five children with unilateral mixed or conductive hearing loss aged 5-12 years of age evaluated the use of the Baha SoundArc compared to their existing Baha Softband in a one month take home trial. Participants had a minimum of 3 months experience using the control, Baha Softband. Participants were assessed at baseline and one month following fit of the Baha SoundArc. Measures included an experience and use patient reported outcome, speech perception testing in quiet using Phonetically Balanced Kindergarten (PBK) words, and sound field audiometry. RESULTS: Mean aided soundfield thresholds across the frequency range were 27.6 dB HL for Softband and 26.0 dB HL for SoundArc, which were not significantly different (P = >.05). Mean word recognition score was 80.8% when aided with the Softband device and 85.1% with the SoundArc, which was also not significantly different (P = >.05). Most children favored the aesthetics and usability of the SoundArc over Softband, but comfort ratings were largely similar for both devices. CONCLUSIONS: Bone conduction sound processors mounted on a SoundArc or a Softband resulted in comparable improvements in aided thresholds and speech understanding in children suffering from conductive or mixed hearing loss. Both wearing modalities can be considered equivalent in terms of audiological outcomes, although both patients and clinicians preferred the usability and aesthetics of the SoundArc. The SoundArc provides an alternative wearing option for patients that may otherwise be discouraged by the aesthetics and usability of the Softband device. GOV IDENTIFIER: NCT03333577.

Outcomes and device use in children with bone-conduction hearing devices in South Africa.

BACKGROUND:  Bone-conduction hearing devices (BCHD) can provide hearing solutions in settings where middle ear pathology is rife. OBJECTIVES:  Describe functional hearing outcomes and device use of children fitted with BCHD. METHOD:  Retrospective review of 79 children fitted with BCHD between January 2017 and May 2022. Outcomes included device use and subjective reports measured with the Parents' Evaluation of Aural/Oral Performance of Children (PEACH) and the Teachers' Evaluation of Aural/Oral Performance of Children (TEACH). Analysis of variance established association between mean data logging and type and degree of hearing loss. Thematic analyses were done for qualitative outcomes. RESULTS:  Average usage was 7.0 h/day (5.4 SD; range 0.1-24). PEACH ratings indicated 93.3% of children wore their BCHD 'always' or 'often', with 80% displaying Typical auditory performance at 1-month follow-up. TEACH ratings indicated 84.2% of children wore their BCHD 'always' or 'often', with 78.9% showing typical auditory behaviour. Increased usage was noted for conductive, mixed, moderate and severe hearing losses. There was a mean delay of 17.2 months (23.4 SD; range 0-90) between age of diagnosis and fitting. Thematic analyses identified two main themes: advantages and barriers to BCDH use. CONCLUSION:  Average device use fell short of the internationally recommended 10 h/day. Higher BCHD use was associated with higher functional listening performance scores. Long waiting times for medical or surgical intervention for conductive hearing losses can delay BCHD fitting.Contribution: Limited information is available to examine outcomes in children fitted with BCHD.

The effect of local dexamethasone on stapedotomy surgery outcomes in patients with otosclerosis.

BACKGROUND: Some studies have shown a positive effect of systemic corticosteroid on hearing results after stapedotomy, but its side effects can limit its routine administration. AIM: The aim of this study was to investigate the effect of local dexamethasone on the results of stapedotomy surgery. MATERIAL AND METHODS: Fifty two patients undergone stapedotomy surgery for otosclerosis involved. In the case group after stapedotomy we fulfilled the middle ear with dexamethasone and then the placement of the prosthesis was done. In the control group after stapedotomy we did not use dexamethasone in the middle ear. RESULTS: Gender, age, nausea, vomiting, postoperative vertigo and nystagmus did not significantly differ between the groups. A significant difference was observed in tinnitus rate between two groups. In the case group ABG decrease was higher and bone conduction thresholds improved at frequencies of 1000, 2000, and 4000 three months after surgery. CONCLUSION: Since local dexamethasone had a positive effect on the results of stapedotomy surgery, it can be used instead of systemic corticosteroids to reduce the side effects and increasing surgery's success rate. SIGNIFICANCE: If local dexamethasone had a positive influence on the results of stapedotomy surgery, it can be used instead of systemic corticosteroids to reduce the side effects and increasing surgery's success rate.

Comparison of Quality of Life Outcomes for Percutaneous Versus Transcutaneous Implantable Hearing Devices: A Systematic Review and Meta-analysis.

OBJECTIVE: To compare quality of life (QOL) outcomes of percutaneous and transcutaneous bone conduction devices (pBCD and tBCD, respectively). DATABASES REVIEWED: Pubmed, Scopus, CINAHL. METHODS: A systematic review was performed searching for English language articles from inception to March 15, 2023. Studies reporting QOL outcomes measured using a validated tool following implantation of either pBCDs or tBCDs were considered for inclusion. QOL outcomes included scores for Glasgow Benefit Inventory, Glasgow Children's Benefit Inventory, Abbreviated Profile of Hearing Aid Benefit, and the Speech, Spatial, and Qualities of Hearing Scale. A meta-analysis of continuous measures was performed. RESULTS: A total of 52 articles with 1,469 patients were included. Six hundred eighty-nine patients were implanted with pBCDs, and the remaining 780 were implanted with tBCDs. Average Glasgow Benefit Inventory scores for the tBCD group (33.0, 95% confidence interval [22.7-43.3]) were significantly higher than the pBCD group (30.9 [25.2-36.6]) (Δ2.1 [1.4-2.8], p < 0.0001). Mean Glasgow Children's Benefit Inventory scores (Δ3.9 [2.0-5.8], p = 0.0001) and mean gain in Abbreviated Profile of Hearing Aid Benefit scores (Δ5.6 [4.8-6.4], p < 0.0001) were significantly higher among patients implanted with tBCDs than those implanted with pBCDs. Patients implanted with tBCDs also had significantly higher gains on the Speech (Δ1.1 [0.9-1.3], p < 0.0001), Spatial (Δ0.8 [0.7-0.9], p < 0.0001), and Qualities of Hearing (Δ1.2 [1.1-1.3], p < 0.0001) portions of the Speech, Spatial, and Qualities of Hearing Scale than those implanted with pBCDs. CONCLUSIONS: Patients implanted with transcutaneous devices had better QOL outcomes than those implanted with percutaneous devices.

Magnetic Resonance Imaging Artifact Associated With Transcutaneous Bone Conduction Implants: Cholesteatoma and Vestibular Schwannoma Surveillance.

OBJECTIVE: To evaluate the magnetic resonance (MR) image artifact and image distortion associated with the two transcutaneous bone conduction implants currently available in the United States. STUDY DESIGN: Cadaveric study. METHODS: Two cadaveric head specimens (1 male, 1 female) were unilaterally implanted according to manufacturer guidelines and underwent MR imaging (General Electric and Siemens 1.5 T scanners) under the following device conditions: (1) no device, (2) Cochlear Osia with magnet and headwrap, (3) Cochlear Osia without magnet, and (4) MED-EL Bonebridge with magnet. Maximum metal mitigation techniques were employed in all conditions, and identical sequences were obtained. Blinded image scoring (diagnostic vs nondiagnostic image) was performed by experienced neuroradiologists according to anatomical subsites. RESULTS: All device conditions produced artifact and image distortion. The Osia with magnet produced diagnostic T1- and T2-weighted images of the ipsilateral temporal bone, however, non-echo planar imaging diffusion-weighted imaging (DWI) was nondiagnostic. The Osia without magnet scanned on the Siemens MR imaging demonstrated the least amount of artifact and was the only condition that allowed for diagnostic imaging of the ipsilateral temporal bone on DWI. The Bonebridge produced a large area of artifact and distortion with the involvement of the ipsilateral and contralateral temporal bones. CONCLUSION: In summary, of the three device conditions (Osia with magnet, Osia without magnet, and Bonebridge), Osia without magnet offered the least amount of artifact and distortion and was the only condition in which diagnostic DWI was available for the middle ear and mastoid regions on the Siemens MR imaging scanner.

Role of early hearing aid experience in speech recognition in patients with bilateral congenital microtia following Bonebridge implantation: a retrospective cohort study.

PURPOSE: To identify audiological and demographic variables that predict speech recognition abilities in patients with bilateral microtia who underwent Bonebridge (BB) implantation. METHODS: Fifty patients with bilateral microtia and bilateral conductive hearing loss (CHL) who underwent BB implantation were included. Demographic data, preoperative hearing aid use experience, and audiological outcomes (including pure-tone hearing threshold, sound field hearing threshold [SFHT], and speech recognition ability) for each participant were obtained. The Chinese-Mandarin Speech Test Materials were used to test speech recognition ability. The word recognition score (WRS) of disyllabic words at 65 dB SPL signals was measured before and after BB implantation in quiet and noisy conditions. RESULTS: The mean preoperative WRS under quiet and noisy conditions was 10.44 ± 12.73% and 5.90 ± 8.76%, which was significantly improved to 86.38 ± 9.03% and 80.70 ± 11.34%, respectively, following BB fitting. Multiple linear regression analysis revealed that lower preoperative SFHT suggested higher preoperative WRS under both quiet and noisy conditions. Higher age at implantation predicted higher preoperative WRS under quiet conditions. Furthermore, patients with more preoperative hearing aid experience and lower postoperative SFHT were more likely to have higher postoperative WRS under both quiet and noisy testing conditions. CONCLUSIONS: This study represents the first attempt to identify predictors of preoperative and postoperative speech recognition abilities in patients with bilateral microtia with BB implantation. These findings emphasize that early hearing intervention before implantation surgery, combined with appropriate postoperative fitting, contributes to optimal benefits in terms of postoperative speech recognition ability.

Clinical performance, safety, and patient-reported outcomes of an active osseointegrated bone-conduction hearing implant system at 24-month follow-up.

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.

A Novel Method to Determine the Maximum Output of Individual Patients for an Active Transcutaneous Bone Conduction Implant Using Clinical Routine Data.

OBJECTIVES: The maximum output provided by a bone conduction (BC) device is one of the main factors that determines the success when treating patients with conductive or mixed hearing loss. Different approaches such as sound pressure measurements using a probe microphone in the external auditory canal or a surface microphone on the forehead have been previously introduced to determine the maximum output of active transcutaneous BC devices that are not directly accessible after implantation. Here, we introduce a method to determine the maximum output hearing level (MOHL) of a transcutaneous active BC device using patients' audiometric data. DESIGN: We determined the maximum output in terms of hearing level MOHL (dB HL) of the Bonebridge using the audiometric and direct BC threshold of the patient together with corresponding force levels at hearing threshold and the maximum force output of the device. Seventy-one patients implanted with the Bonebridge between 2011 and 2020 (average age 45 ± 19 years ranging from 5 to 84 years) were included in this study. The analyses of MOHLs were performed by (1) dividing patients into two groups with better or worse average audiometric BC threshold (0.5, 1, 2, 4 kHz), on the ipsilateral side or (2) by separating the MOHLs based on better or worse frequency-by-frequency specific audiometric BC thresholds on the ipsilateral (implanted) side. RESULTS: When using a frequency-by-frequency analysis obtained average ipsilateral MOHLs were in the range between 51 and 73 dB HL for frequencies from 0.5 to 6 kHz in the group with better audiometric BC threshold on the ipsilateral ears. The average contralateral MOHLs in the group with better contralateral hearing were in the range from 43 to 67 dB HL. The variability of the data was approximately 6 to 11 dB (SDs) across measured frequencies (0.5 to 6 kHz). The average MOHLs were 4 to 8 dB higher across frequencies in the group with better audiometric BC threshold on the ipsilateral ears than in the group with better audiometric BC threshold on the contralateral ears. The differences between groups were significant across measured frequencies ( t test; p < 0.05). CONCLUSIONS: Our proposed method demonstrates that the individual frequency-specific MOHL on the ipsilateral and contralateral side of individual patients with a transcutaneous BC device can be determined mainly using direct and audiometric BC threshold data of the patients from clinical routine. The average MOHL of the implant was found 4 to 8 dB higher on the ipsilateral (implanted) side than on the contralateral side.

Post-implantation clinical cost analysis between transcutaneous and percutaneous bone conduction devices.

INTRODUCTION: Bone conduction devices (BCD) are effective for hearing rehabilitation in patients with conductive and mixed hearing loss or single-sided deafness. Transcutaneous bone conduction devices (tBCD) seem to lead to fewer soft tissue complications than percutaneous BCDs (pBCD) but have other drawbacks such as MRI incompatibility and higher costs. Previous cost analyses have shown a cost advantage of tBCDs. The purpose of this study is to compare long-term post-implantations costs between percutaneous and transcutaneous BCDs. MATERIALS AND METHODS: Retrospective data from 77 patients implanted in a tertiary referral centre with a pBCD (n = 34), tBCD (n = 43; passive (tpasBCD; n = 34) and active (tactBCD; n = 9) and a reference group who underwent cochlear implantation (CI; n = 34), were included in a clinical cost analysis. Post-implantation costs were determined as the sum of consultation (medical and audiological) and additional (all post-operative care) costs. Median (cumulative) costs per device incurred for the different cohorts were compared at 1, 3 and 5 years after implantation. RESULTS: After 5 years, the total post-implantation costs of the pBCD vs tpasBCD were not significantly different (€1550.7 [IQR 1174.6-2797.4] vs €2266.9 [IQR 1314.1-3535.3], p = 0.185), nor was there a significant difference between pBCD vs tactBCD (€1550.7 [1174.6-2797.4] vs €1428.8 [1277.3-1760.4], p = 0.550). Additional post-implantation costs were significantly highest in the tpasBCD cohort at all moments of follow-up. CONCLUSION: Total costs related to post-operative rehabilitation and treatments are comparable between percutaneous and transcutaneous BCDs up to 5 years after implantation. Complications related to passive transcutaneous bone conduction devices appeared significantly more expensive after implantation due to more frequent explantations.

Efficacy of the Bonebridge BCI602 for Adult Patients with Single-sided Deafness: A Prospective Multicenter Study.

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.

Prediction of postoperative speech comprehension with the transcutaneous partially implantable bone conduction hearing system Osia®.

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.

Surgical Outcomes of Modified Technique for Transcutaneous Bone Conduction Hearing Aid Implantation.

OBJECTIVE: To detail a modified surgical technique for implantation of the Osia 2 Bone Conduction Hearing Aid (BCHA) system and to assess intra- and postoperative outcomes of this technique. METHODS: A retrospective review was performed for cases undergoing implantation of an Osia 2 BCHA at a tertiary academic medical center. Modifications were made to the surgical procedure including: horizontal or curvilinear incisions, placement of the osseointegrated screw slightly superior to the plane of the external auditory canal, and double layer wound closure. Data regarding outcomes including demographics, incision type, surgical time, drilling requirements, and complications were collected using the electronic medical record. RESULTS: A total of twenty-eight cases were evaluated with 57.1% and 42.9% utilizing horizontal and curved incisions, respectively. The median age for recipients was 43.1 years with six pediatric cases included in the study. Median operative time was 58 min (43-126 min). The majority of cases required minimal (60.7%) or no drilling (28.6%) with a significant increase in operative time for those requiring moderate drilling versus minimal to no drilling (F = 8.02, p = 0.002). There were no intraoperative complications. One (3.6%) postoperative seroma occurred which resolved with conservative management. CONCLUSION: The proposed modified surgical technique is a safe and effective method for implantation of the transcutaneous BCHA system with a low complication rate. Keys include incision design, implant placement, and two-layered closure to minimize wound tension. These modifications can improve ease of the procedure and reduce operative time. These techniques also appear to be applicable to the pediatric population. LEVEL OF EVIDENCE: 3 Laryngoscope, 134:2401-2404, 2024.

Short-term safety and effectiveness of the mCLIP partial prosthesis.

PURPOSE: This multicentric, retrospective study aimed to analyze the short-term safety and effectiveness of the mCLIP Partial Prosthesis. METHODS: Patients underwent tympanoplasty with implantation of a mCLIP Partial Prosthesis. Follow-up examination included ear microscopy and pure-tone audiometry to determine the post-operative pure tone average of the frequencies 0.5, 1, 2 and 3 kHz (PTA4). The post-operative PTA4 air bone gap (ABG) was used to evaluate the audiological outcome. A post-operative minimum and maximum follow-up period was not defined. Thus, the follow-up times of each study center were different, which resulted in different follow-up times for the audiological analysis and for adverse events (AE). RESULTS: 72 (66 adults, 6 children) patients were implanted with the mCLIP Partial Prosthesis. 68 (62 adults, 6 children) patients underwent audiological examination; all 72 patients were examined for adverse events. All patients (N = 68): 72.1% of the patients showed a PTA4 ABG of ≤ 20 dB. Individual post-operative bone conduction (BC) PTA4 thresholds were stable in 67 patients. The mean post-operative follow-up time was 78 ± 46 days. Children (N = 6): 5 out of 6 children showed a PTA4 ABG of ≤ 20 dB. None of the children reported a BC PTA4 deterioration of > 10 dB HL after the implantation. The mean post-operative follow-up time was 101 ± 45 days. Adverse events (all patients, N = 72): 15 (14 adults, 1 child) patients had AEs (27 AEs and 2 Follow-Ups). The mean post-operative follow-up time was 375 days. CONCLUSION: Clinical data show satisfactory audiological parameters after implantation of the mCLIP Partial Prosthesis. The prosthesis is safe and effective for implantation in children and adults. TRIAL REGISTRATION NUMBER: NCT05565339, 09 September 2022, retrospectively registered.

Comparison of Transcutaneous and Percutaneous Implantable Hearing Devices for the Management of Congenital Aural Atresia: A Systematic Review and Meta-Analysis.

OBJECTIVE: To compare audiometric outcomes, complications, and revisions required for percutaneous (pBCD) versus transcutaneous (tBCD) implantable bone-conduction devices for the treatment of hearing loss associated with congenital aural atresia (CAA).Databases Reviewed.PubMed, Scopus, CINAHL. METHODS: A systematic review was performed searching for English language articles from inception to December 14, 2022. Studies reporting audiometric outcomes or complications for either pBCDs or tBCDs for the treatment of CAA were selected for inclusion. A meta-analysis of single means and meta-analysis of proportions with comparison (Δ) of weighted proportions was conducted. RESULTS: A total of 56 articles with 756 patients were selected for inclusion. One hundred ninety patients were implanted with pBCDs, whereas the remaining 566 were implanted with tBCDs. Mean pure-tone audiometry improvement in the pBCD group (39.1 ± 1.1 dB) was significantly higher than in the tBCD group (34.6 ± 1.6 dB; Δ4.5 dB; 95% confidence interval, 4.2-4.7 dB; p < 0.0001). The average improvement in speech reception threshold was 38.6 ± 2.5 dB in the percutaneous group as compared with 32.7 ± 1.6 dB in the transcutaneous group (Δ5.9 dB [5.3-6.5 dB], p < 0.0001). Overall complication rates for patients implanted with pBCDs and tBCDs were 29.0% (15.7-44.4%) and 9.4% (6.5%-13.0%), respectively (Δ19.6% [12.0-27.7%], p < 0.0001). CONCLUSIONS: Patients with CAA implanted with pBCDs had significantly better audiometric outcomes than those implanted with tBCDs. However, complication rates were significantly higher among the pBCD group.

Long-Term Follow-Up in Active Transcutaneous Bone Conduction Implants.

OBJECTIVE: To evaluate long-term outcomes of active transcutaneous bone conduction implants (atBCIs) regarding safety, hearing, and quality of life. STUDY DESIGN: A clinical study with retrospective medical record analysis combined with prospective audiometry and quality of life questionnaires. SETTING: Three secondary to tertiary care hospitals. PATIENTS: All subjects operated with an atBCI in three regions in Sweden were asked for informed consent. Indications for atBCI were single-sided deafness (SSD) and conductive or mixed hearing loss (CMHL). INTERVENTION: Evaluation of atBCI. MAIN OUTCOME MEASURES: Pure tone and speech audiometry and Glasgow Benefit Inventory (GBI). RESULT: Thirty-three subjects were included and 29 completed all parts. The total follow-up time was 124.1 subject-years. Nineteen subjects had CMHL and in this group, pure tone averages (PTA4) were 56.6 dB HL unaided and 29.6 dB HL aided, comparable with a functional gain of 26.0 dB. Effective gain (EG) was -12.7 dB. With bilateral hearing, Word Recognition Scores (WRS) in noise were 36.5% unaided and 59.1% aided. Fourteen subjects had SSD or asymmetric hearing loss (AHL) and in this group, PTA4 were >100 dB HL unaided and 32.1 dB HL aided with the contralateral ear blocked. EG was -9.1 dB. With bilateral hearing, WRSs were 53.2% unaided and 67.9% aided. The means of the total GBI scores were 31.7 for CMHL and 23.6 for SSD/AHL. CONCLUSION: Few complications occurred during the study. The atBCI is concluded to provide a safe and effective long-term hearing rehabilitation.

Measurements of bone-conducted sound in the chinchilla external ear.

We measure bone-conduction (BC) induced skull velocity, sound pressure at the tympanic membrane (TM) and inner-ear compound-action potentials (CAP) before and after manipulating the ear canal, ossicles, and the jaw to investigate the generation of BC induced ear-canal sound pressures and their contribution to inner-ear BC response in the ears of chinchillas. These measurements suggest that in chinchilla: i.) Vibrations of the bony ear canal walls contribute significantly to BC-induced ear canal sound pressures, as occluding the ear canal at the bone-cartilaginous border causes a 10 dB increase in sound pressure at the TM (PTM) at frequencies below 2 kHz. ii.) The contributions to PTM of ossicular and TM motions when driven in reverse by BC-induced inner-ear sound pressures are small. iii.) The contribution of relative motions of the jaw and ear canal to PTM is small. iv.) Comparison of the effect of canal occlusion on PTM and CAP thresholds point out that BC-induced ear canal sound pressures contribute significantly to bone-conduction stimulation of the inner ear when the ear canal is occluded.

The Relationship Between Auditory Performances and Satisfaction of Unilateral Bone-Anchored Hearing in Conductive and Mixed Hearing Loss.

BACKGROUND: The aim of this study is to investigate the deviced and non-deviced auditory performance results of patients with unilateral bone-anchored hearing aid. METHODS: Deviced and non-deviced free field hearing thresholds, speech discrimination, and sentence discrimination scores were evaluated. Shortened profile of the benefit from the hearing instrument (Abbreviated Profile of Hearing Aid Benefit) was used. RESULTS: A total of 17 patients participated in the study. The mean age was 37.9 ± 17.1 years. There was a statistically significant difference between the Abbreviated Profile of Hearing Aid Benefit satisfaction questionnaire and total scores, Background Noise (BN), Reverberation (RV) subscales according to device status (P -lt; .05). No significant difference was found between the Abbreviated Profile of Hearing Aid Benefit total score result of the group divided by the hearing aid threshold (P -gt; .05). No significant difference was found between the Abbreviated Profile of Hearing Aid Benefit total score result of the group divided by the threshold without a hearing aid (P -gt; .05). CONCLUSION: Bone-implanted hearing aids are effective and reliable amplification methods in patients with conductive and mixed hearing loss. Positive results of patient satisfaction and evaluation inventories were obtained from this study.