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.

The Stapes Head Coupler-A Flexible and Safe Option for Vibroplasty.

OBJECTIVE: To investigate the surgical approach and the audiological outcome of a stapes head coupler in active middle ear implant surgery. STUDY DESIGN: Retrospective data analysis. SETTING: Tertiary referral center with a large active middle ear implant program. PATIENTS: Twelve patients with active middle ear implant surgery. INTERVENTIONS: Therapeutic surgical approach for hearing rehabilitation in human subjects. MAIN OUTCOME MEASURES: Auditory brainstem response, sound field thresholds, vibrogram, speech perception in the Freiburger monosyllabic word test. RESULTS: The stapes head was attached safely in different coupling situations. Audiological outcomes were similar to the audiological performance of established vibroplasty couplers presented in the literature. CONCLUSION: The stapes head coupler is a new and safe tool for vibroplasty with a good audiological outcome.

Surgical and audiological outcomes with a new transcutaneous bone conduction device with reduced transducer thickness in children.

PURPOSE: Due to smaller bone thickness, young children with conductive or mixed hearing loss or single-sided deafness were previously most commonly treated with a percutaneous osseointegrated bone-anchored hearing aid (BAHA) or an active middle-ear implant. While the BAHA increases the risk of implant infections, skin infection, overgrowth of the screw or involvement of the implant in head trauma, middle-ear implant surgery involves manipulation of the ossicles with possible risk of surgical trauma. These complications can be omitted with transcutaneous bone conduction implant systems like the MED-EL Bonebridge system. The purpose of this study was to analyze whether the second generation of the Bonebridge (BCI 602) that features a decreased implant thickness with a reduced surgical drilling depth can be implanted safely in young children with good postoperative hearing performance. METHODS: In this study, 14 patients under 12 years were implanted with the second generation of the Bonebridge. Preoperative workup comprised a CT scan, an MRI scan, pure tone audiometry, or alternatively a BERA (bone conduction, air conduction). Since children under 12 years often have a lower bone thickness, the CT was performed to determine the suitability of the temporal bone for optimal implant placement using the Otoplan software. RESULTS: All patients (including three under the age of five) were successfully implanted and showed a good postoperative hearing performance. CONCLUSION: With adequate preoperative workup, this device can be safely implanted in children and even children under 5 years of age and allows for an extension of indication criteria toward younger children.

Bonebridge® bone conduction implant. Hearing outcomes and quality of life in patients with conductive/mixed hearing loss.

PURPOSE: The aim of this study was to analyze the hearing outcomes and quality of life in a series of 52 patients affected by conductive or mixed hearing loss and treated with Bonebridge®. METHODS: 52 of 71 patients implanted with Bonebridge® between October 2012 and January 2022, were included in the study. We compared the air conduction thresholds at the frequencies 500, 1000, 2000, 3000, 4000 Hz, the SRT50% and the World Recognition Score at an intensity of 50 dB with and without the implant. The Abbreviated Profile of Hearing Aid Benefit (APHAB) was employed to assess the quality of life of patients. RESULTS: The liminal tone audiometry (free field) pure tone average for air conduction after 6 months with the implant was 35.12 dB, obtaining a mean gain of 31.83 dB. With Bonebridge®, the mean SRT was 34.17 dB, whereas before the surgery no patient achieved 50% of correct answers at a sound intensity of 50 dB. The world recognition score at 50 dB changed from 11% without the implant to 85% with it. We observed one case of implant failure and one case of implant exposure. The APHAB questionnaire showed an improvement after implantation in practically all the subscales. CONCLUSIONS: The hearing outcomes and the subjective benefits reported by patients obtained in our study are similar to those published in the literature. Bonebridge® represents an excellent method for the rehabilitation of patients with conductive and mixed hearing loss, showing a low rate of complications.

The Oticon Ponto System in Adults With Severe-to-Profound and Mixed Hearing Loss: Audiologic Outcomes and Patient Satisfaction.

OBJECTIVE: To measure audiologic outcomes and self-assessed satisfaction with the Ponto system in a group of patients who had severe to profound and mixed hearing loss. STUDY DESIGN: Retrospective case review. SETTING: Tertiary referral center. PATIENTS: Sixteen patients aged 21 to 74 years with severe-to-profound and mixed hearing loss (bone conduction thresholds, ≥45 dB HL). INTERVENTIONS: Ponto implant surgery. MAIN OUTCOME MEASURES: Pure-tone audiometry, free-field hearing thresholds, effective gain, word recognition score in quiet, and speech reception threshold (SRT) in noise were assessed. Patient-reported outcomes were collected using the Clinical Global Impression Scale, Glasgow Benefit Inventory, and Abbreviated Profile of Hearing Aid Benefit. Information concerning any medical complications was also gathered. RESULTS: Both word recognition score and SRT were significantly better after 12 months compared with before surgery. At normal speech level (65 dB SPL), 12 of 16 users had speech discrimination ≥70%. However, at the 12-month follow-up, the average effective gain was -6.2 dB. In general, the self-report outcomes showed good satisfaction in most patients. Postoperatively, skin complications were noted in six patients, of whom two underwent reoperation. All patients were still using the Ponto after an average observation time of 2.7 years. CONCLUSION: Although skin complications were not uncommon, the Ponto system seems to be an effective method of improving hearing performance and provides subjective satisfaction in real-life situations in patients with severe-to-profound and mixed hearing loss. However, considering the significantly increased bone conduction thresholds and the risk of their further deterioration, long-term follow-up is still needed.

The bone conduction implant BONEBRIDGE increases quality of life and social life satisfaction.

PURPOSE: Transcutaneous active bone conduction hearing aids represent an alternative approach to middle ear surgery and conventional hearing aids for patients with conductive or mixed hearing loss. The aim of this study was to determine quality of life, subjective hearing experience and patients' satisfaction after implantation of a bone conduction hearing aid. METHODS: This monocentric and retrospective study included twelve adult patients who received a bone conduction hearing aid (Bonebridge, MedEL) consisting of an extracorporeal audio processor and a bone conduction implant (BCI) between 2013 and 2017. On average 40 months after implantation, the patients were asked to answer three questionnaires regarding quality of life (AqoL-8D), self-reported auditory disability (SSQ-12-B) and user's satisfaction (APSQ) after implantation of the Bonebridge (BB). A descriptive statistical analysis of the questionnaires followed. RESULTS: 12 patients aged 26-85 years (sex: m = 7, w = 5) were recruited. The quality of life of all patients after implantation of the BB (AqoL 8D) averaged an overall utility score of 0.76 (SD ± 0.17). The mean for 'speech hearing' in the SSQ-12-B was + 2.43 (SD ± 2.03), + 1.94 (SD ± 1.48) for 'spatial hearing' and + 2.28 (SD ± 2.32) for 'qualities of hearing'. 11 out of 12 patients reported an improvement in their overall hearing. The APSQ score for the subsection 'wearing comfort' was 3.50 (SD ± 0.87), 'social life' attained a mean of 4.17 (SD ± 1.06). The 'device inconveniences' reached 4.02 (SD ± 0.71) and 'usability' of the device was measured at 4.23 (SD ± 1.06). The average wearing time of the audio processor in the cohort was 11 h per day, with 8 of 12 patients reporting the maximum length of 12 h per day. CONCLUSION: BB implantation results in a gain in the perceived quality of life (AqoL 8D). The SSQ-12-B shows an improvement in subjective hearing. According to the APSQ, it can be assumed that the BB audio processor, although in an extracorporeal position, is rated as a useful instrument with positive impact on social life. The majority stated that they had subjectively benefited from BB implantation and that there were no significant physical or sensory limitations after implantation.

Combination of Direct Oval Window Vibroplasty With Customized Partial Ossicular Replacement Prosthesis (PORP): A Novel Reconstruction Technique to Rehabilitate Mixed Hearing Loss.

OBJECTIVE: Hearing rehabilitation with an active middle ear implant (AMEI) in patients with mixed hearing loss (MHL) after multiple ear surgeries is surgically challenging and requires individual solutions in some cases. Our objective was to introduce a feasible novel technique for direct oval window vibroplasty (OW vibroplasty) using a partial ossicular replacement prosthesis (PORP) to ensure stability and enable active and passive sound transmission. DESIGN: Four patients with MHL following multiple middle ear surgeries and indication for an AMEI received direct OW vibroplasty in combination with a customized PORP between the enwrapped actuator and reconstructed tympanic membrane (TM). RESULTS: Postoperative bone conduction was stable in all patients. All patients benefitted from the AMEI in combination with PORP with a mean functional gain of 31.5 ±â€Š17.0 dB. Mean aided postoperative pure tone average was 27.3 ±â€Š2.6 dB. Speech discrimination in quiet at 65 dB with the German Language Freiburg Monosyllabic Test improved for all patients to 68.8 ±â€Š6.3% and in noise with the German Language Oldenburger Sentence Test to -10.4 ±â€Š3.3 dB SNR. No complications were observed. CONCLUSIONS: This novel technique of direct OW vibroplasty extends the portfolio of reconstructive middle ear procedures by combining an intraoperatively customized "off-the-shelf" PORP as a coupler between floating mass transducer (FMT) and a cartilage TM. We found satisfying functional hearing results. Benefits of the reported technique comprise 1) stabilization and optimized coupling of the reconstruction, 2) possibility of passive sound transmission, 3) general feasibility due to great availability of a regular PORP, and 4) flexibility in bridging of large gaps between TM and actuator.

Long term results and evaluation of device satisfaction in patients used the vibrant sound bridge (VSB).

BACKGROUND: Patients' satisfaction with the device is as important as the audiological gains in patients using these devices. OBJECTIVE: In this study, we aimed to evaluate the hearing aid satisfaction of individuals using The Vibrant Sound Bridge (VSB) (Vibrant Med-El, Innsbruck, Austria) and to compare this result with audiologic results ​​with and without devices. MATERIAL AND METHODS: Patients who were using VSB were included in the study. Preoperative and postoperative pure tone averages and demographic datas of the patients to be included in the study were recorded. A shortened version of Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire, was used to evaluate patients' device satisfaction. RESULTS: Fifteen patients with VSB were included in the study. The mean follow-up was 9.13 years. The preoperative air conduction threshold and the air-bone gap in all frequencies were significantly higher than postoperative values (p < .05). The functional gain was found as 28 dB. In the APHAB questionnaire, there was a significant difference between total score results and EC, BN, RV subscales in the patients using the device (p < .01). CONCLUSION AND SIGNIFICANCE: Patients with VSB give satisfactory results in auditory gains. In particular, good indication and long-term use of the device increases the suitability and satisfaction of the patients.

Piezoelectric bone conduction hearing implant Osia® - audiological and quality of life benefits.

<b>Introduction:</b> Nowadays, there are many options to treat hearing-impaired patients: tympanoplastic surgery, hearing aids and a wide range of implantable devices.</br></br> <b>Aim:</b> The aim of this study is to present the mid-term audiological and quality of life benefits after the implantation of Osia®, an active piezoelectric bone conduction hearing implant. </br></br> <b>Material and methods:</b> The state of the tissues in the implanted area, as well as audiological and quality of life results were analyzed at six, nine and twelve months after implantation in a group of four adult patients with bilateral mixed hearing loss (1 after bilateral canal-wall-down mastoidectomy, 2 with chronic simple otitis media and after myringoplasty in the opposite ear, 1 with bilateral otosclerosis and after stapedotomy in the opposite ear). </br></br> <b>Results:</b> No postoperative complications were found in any of the cases. One year after surgery the mean audiological gain in FF PTA4 (pure tone average for 0.5, 1, 2, and 4 kHz) was 52.2 ± 3.5 dB in comparison to the unaided situation, the mean speech understanding with Osia® in quiet was 90 ± 8.2% for 50 dB SPL, 98.8 ± 2.5% for 65 dB SPL and 100 ± 0% for 80 dB SPL, and the mean speech understanding with Osia® in noise was 37.5% ± 23.6 for 50 dB SPL, 93.8 ± 4.8% for 65 dB SPL and 98.8 ± 2.5% for 80 dB SPL. There was also an evident improvement in the quality of hearing as well as in the quality of life, measured by APHAB (Abbreviated Profile of Hearing Aid Benefit) and SSQ (Speech, Spatial and Qualities of Hearing Scale). </br></br> <b>Conclusions:</b> The Osia® is an effective treatment option for patients with bilateral mixed hearing loss. The mid-term audiological and quality of life results are excellent, but further observations including bigger groups of patients and a longer follow- -up are required.

A retrospective European multicenter analysis of the functional outcomes after active middle ear implant surgery using the third generation vibroplasty couplers.

PURPOSE: To evaluate the safety and performance of three novel vibroplasty couplers that allow attachment of the floating mass transducer of a transcutaneous active middle ear implant (AMEI) to the round window (RW) membrane, the long process (LP), or the incus body and the short process (SP) of the incus. METHODS: Retrospective multicenter cohort study of 25 AMEI users with sensorineural or mixed hearing loss that were among the first implanted with an AMEI vibrating ossicular prosthesis in combination with the third generation of vibroplasty couplers between 2014 and 2016. Main Outcome Measures were bone-conduction pure-tone and vibroplasty thresholds, postoperative aided sound field thresholds and postoperative aided word recognition score (WRS). RESULTS: Bone conduction threshold changes of more than 10 dB in 4PTABC were observed in two subjects. A mean improvement of 57.8% in speech recognition was observed with a mean WRS at 65 dB SPL improving from 14.8% (SD 21.9%) preoperatively to a mean aided score of 72.6% (SD 18.6%). Sound field thresholds improved from an average 4PTASF of 64.1 dB HL (SD 9.8 dB HL) to 37.0 dB HL (SD 8.9 dB HL), resulting in a mean functional gain of 27.1 dB. There was no significant difference in WRS or functional gain between the coupler types. CONCLUSION: Initial experience shows that all three third generation vibroplasty couplers represent safe and efficient attachment options for the FMT allowing the surgeon to choose the coupling type based on the present pathology.

Patient-reported long-term benefit with an active transcutaneous bone-conduction device.

PURPOSE: To evaluate the long-term benefits in hearing-related quality of life, patient satisfaction and wearing time of patients rehabilitated with an active transcutaneous bone-conduction device. Adverse events and audiological outcomes are reported as secondary outcomes. METHODS: This retrospective, mono-centric cohort analysis involves 16 adults with conductive or mixed hearing loss with a mean device experience of 51.25 months. Patient-reported outcome measures were assessed using the short version of the Speech, Spatial and Qualities of Hearing Scale (SSQ12-B) and the German version of the Audio Processor Satisfaction Questionnaire (APSQ). Audiological outcomes as well as incidence of adverse events were obtained from patients´ charts. RESULTS: The hearing-related quality of life improved significantly within all subscales of the SSQ12-B scoring a mean overall of 2.95 points. Patient satisfaction measured with the APSQ scored 8.8 points on average. Wearing times differed considerably and patients with lower levels of education seemed to use their device longer compared to patients with academic education. Eight minor adverse events were documented, all of which resolved during follow-up. The mean gain in word recognition score at the last follow-up measured at 65 dB was 75.9%, while speech reception threshold was lowered by 35.1 dB. CONCLUSION: Even after several years, patients report significant benefits in hearing-related quality of life and device satisfaction. In combination with a low rate of minor adverse events and significantly improved audiological outcomes, the device is considered as a comfortable and effective option in hearing rehabilitation.

The BONEBRIDGE active transcutaneous bone conduction implant: effects of location, lifts and screws on sound transmission.

BACKGROUND: The BONEBRIDGE (MED-EL, Innsbruck, Austria) is a bone-conduction implant used in the treatment of conductive and mixed hearing loss. The BONEBRIDGE consists of an external audio processor and a bone-conduction floating mass transducer that is surgically implanted into the skull in either the transmastoid, retrosigmoid or middle fossa regions. The manufacturer includes self-tapping screws to secure the transducer; however, self-drilling screws have also been used with success. In cases where the skull is not thick enough to house the transducer, lifts are available in a variety of sizes to elevate the transducer away from the skull. The objective of the present study was to investigate the effects of screw type, lift thickness, and implant location on the sound transmission of the BONEBRIDGE. METHOD: Six cadaveric temporal bones were embalmed and dried for use in this study. In each sample, a hole was drilled in each of the three implant locations to house the implant transducer. At the middle fossa, six pairs of screw holes were pre-drilled; four pairs to be used with self-tapping screws and lifts (1, 2, 3, and 4 mm thick lifts, respectively), one pair with self-tapping screws and no lifts, and one pair with self-drilling screws and no lifts. At the transmastoid and retrosigmoid locations, one pair of screw holes were pre-drilled in each for the use of the self-tapping screws. The vibration of transmitted sound to the cochlea was measured using a laser Doppler vibrometry technique. The measurements were performed on the cochlear promontory at eight discrete frequencies (0.5, 0.75, 1, 1.5, 2, 3, 4 and 6 kHz). Vibration velocity of the cochlear wall was measured in all samples. Measurements were analyzed using a single-factor ANOVA to investigate the effect of each modification. RESULTS: No significant differences were found related to either screw type, lift thickness, or implant location. CONCLUSIONS: This is the first known study to evaluate the effect of screw type, lift thickness, and implant location on the sound transmission produced by the BONEBRIDGE bone-conduction implant. Further studies may benefit from analysis using fresh cadaveric samples or in-vivo measurements.

Swallowed by the bone - Is skin reaction the "tip of the iceberg"?

The most frequent complications of osseointegrated implantation include implant-site infections, soft tissue overgrowth and failure of osseointegration. Bone overgrowth is also a complication at the abutment site and infrequently reported. We describe a rare case of difficult control and exuberant bone overgrowth, with total implant involvement, in a short period of time never before described in the literature. Bone growth around the implant is frequently underestimated and can be the cause of difficult control of skin reactions, that in some cases is just the "tip of the iceberg". Timely surgical review with removing excess bone may lead to implant preservation and control of skin reaction and healing.

Three-Year Follow-Up with the Bone Conduction Implant.

BACKGROUND: The bone conduction implant (BCI) is an active transcutaneous bone conduction device where the transducer has direct contact to the bone, and the skin is intact. Sixteen patients have been implanted with the BCI with a planned follow-up of 5 years. This study reports on hearing, quality of life, and objective measures up to 36 months of follow-up in 10 patients. METHOD: Repeated measures were performed at fitting and after 1, 3, 6, 12, and 36 months including sound field warble tone thresholds, speech recognition thresholds in quiet, speech recognition score in noise, and speech-to-noise thresholds for 50% correct words with adaptive noise. Three quality of life questionnaires were used to capture the benefit from the intervention, appreciation from different listening situations, and the ability to interact with other people when using the BCI. The results were compared to the unaided situation and a Ponto Pro Power on a soft band. The implant functionality was measured by nasal sound pressure, and the retention force from the audio processor against the skin was measured using a specially designed audio processor and a force gauge. RESULTS: Audiometry and quality of life questionnaires using the BCI or the Ponto Pro Power on a soft band were significantly improved compared to the unaided situation and the results were statistically supported. There was generally no significant difference between the two devices. The nasal sound pressure remained stable over the study period and the force on the skin from the audio processor was 0.71 ± 0.22 N (mean ± 1 SD). CONCLUSION: The BCI improves the hearing ability for tones and speech perception in quiet and in noise for the indicated patients. The results are stable over a 3-year period, and the patients subjectively report a beneficial experience from using the BCI. The transducer performance and contact to the bone is unchanged over time, and the skin area under the audio processor remains without complications during the 3-year follow-up.

Audiological outcome measures with the BONEBRIDGE transcutaneous bone conduction hearing implant: impact of noise, reverberation and signal processing features.

Objective: To assess the performance of an active transcutaneous implantable-bone conduction device (TI-BCD), and to evaluate the benefit of device digital signal processing (DSP) features in challenging listening environments.Design: Participants were tested at 1- and 3-month post-activation of the TI-BCD. At each session, aided and unaided phoneme perception was assessed using the Ling-6 test. Speech reception thresholds (SRTs) and quality ratings of speech and music samples were collected in noisy and reverberant environments, with and without the DSP features. Self-assessment of the device performance was obtained using the Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire.Study sample: Six adults with conductive or mixed hearing loss.Results: Average SRTs were 2.9 and 12.3 dB in low and high reverberation environments, respectively, which improved to -1.7 and 8.7 dB, respectively with the DSP features. In addition, speech quality ratings improved by 23 points with the DSP features when averaged across all environmental conditions. Improvement scores on APHAB scales revealed a statistically significant aided benefit.Conclusions: Noise and reverberation significantly impacted speech recognition performance and perceived sound quality. DSP features (directional microphone processing and adaptive noise reduction) significantly enhanced subjects' performance in these challenging listening environments.

Hearing Aid Treatment in Patients with Mixed Hearing Loss. Part I: Expected Benefit and Limitations after Stapes Surgery.

OBJECTIVE: The purpose of the present study was to determine the fraction of patients with mixed hearing loss who can or cannot expect benefit from power hearing aids (HAs) after stapes surgery. DESIGN: The audiological outcome of 374 stapes surgeries was used to calculate the patients' individual postoperative requirements in terms of gain and output of HAs. These requirements were compared to the available gain and output provided by state-of-the-art power HAs at 0.5, 1.0, 2.0, and 4.0 kHz. According to these comparisons, ears were divided into three groups. For G0, required gain and output lay within the corresponding technical limits of the HAs at all frequencies. In G1, one or both requirements could not be fulfilled at 1 frequency. G2 combined all ears where the requirements lay beyond the HA's technical limitations at 2 or more frequencies. RESULTS: Stapes surgery resulted in an improvement of air-bone gap (ABG) in 84.5% of the cases by 15.7 dB on average. Based on pure-tone average (0.5, 1.0, 2.0, 4.0 kHz), 40.6% of all cases showed an ABG ≤10 dB. 44.9% of all cases did no longer need a HA after stapes surgery. A power HA would fulfill both audiological criteria at all 4 frequencies in 81.6% of cases that needed a HA postoperatively. However, 18.4% would not be sufficiently treatable at 1 or more frequencies (15.0% in G1, 3.4% in G2). CONCLUSIONS: The present study identified a subset of patients with mixed hearing loss after stapes surgery that cannot be treated sufficiently with available power HAs. As the residual ABG is an important reason for this lack of treatment success, the advancement of alternative hearing devices that circumvent the middle ear, such as powerful active middle ear implants, is indicated.

Hearing Aid Treatment for Patients with Mixed Hearing Loss. Part II: Speech Recognition in Comparison to Direct Acoustic Cochlear Stimulation.

BACKGROUND: The conventional therapy for severe mixed hearing loss is middle ear surgery combined with a power hearing aid. However, a substantial group of patients with severe mixed hearing loss cannot be treated adequately with today's state-of-the-art (SOTA) power hearing aids, as predicted by the accompanying part I of this publication, where we compared the available maximum power output (MPO) and gain from technical specifications to requirements for optimum benefit using a common fitting rule. Here, we intended to validate the theoretical assumptions from part I experimentally in a mixed hearing loss cohort fitted with SOTA power hearing aids. Additionally, we compared the results with an implantable hearing device that circumvents the impaired middle ear, directly stimulating the cochlea, as this might be a better option. OBJECTIVES: Speech recognition outcomes obtained from patients with severe mixed hearing loss supplied acutely with a SOTA hearing aid were studied to validate the outcome predictions as described in part I. Further, the results obtained with hearing aids were compared to those in direct acoustic cochlear implant (DACI) users. MATERIALS AND METHODS: Twenty patients (37 ears with mixed hearing loss) were provided and fitted with a SOTA power hearing aid. Before and after an acclimatization period of at least 4 weeks, word recognition scores (WRS) in quiet and in noise were studied, as well as the speech reception threshold in noise (SRT). The outcomes were compared retrospectively to a second group of 45 patients (47 ears) using the DACI device. Based on the severity of the mixed hearing loss and the available gain and MPO of the SOTA hearing aid, the hearing aid and DACI users were subdivided into groups with prediction of sufficient, partially insufficient, or very insufficient hearing aid performance. RESULTS: The patients with predicted adequate SOTA hearing aid performance indeed showed the best WRS in quiet and in noise when compared to patients with predicted inferior outcomes. Insufficient hearing aid performance at one or more frequencies led to a gradual decrease in hearing aid benefit, validating the criteria used here and in the accompanying paper. All DACI patients showed outcomes at the same level as the adequate hearing aid performance group, being significantly better than those of the groups with inadequate hearing aid performance. Whereas WRS in quiet and noise were sensitive to insufficient gain or output, showing significant differences between the SOTA hearing aid and DACI groups, the SRT in noise was less sensitive. CONCLUSIONS: Limitations of outcomes in mixed hearing loss individuals due to insufficient hearing aid performance can be accurately predicted by applying a commonly used fitting rule and the 35-dB dynamic range rule on the hearing aid specifications. Evidently, when outcomes in patients with mixed hearing loss using the most powerful hearing aids are insufficient, bypassing the middle ear with a powerful active middle ear implant or direct acoustic implant can be a promising alternative treatment.

Prevalence of potential candidates for electric-acoustic stimulation implant in a hearing-impaired population.

OBJECTIVE: To estimate the prevalence of potential electric-acoustic stimulation (EAS) implant candidates in a hearing-impaired population through a review of auditory examinations. METHODS: In total, 7356 patients underwent audiometric examination in our department between 2011 and 2014. The prevalence of patients meeting the audiometric criteria for EAS and standard cochlear implant (CI) was assessed. RESULTS: The percentage of EAS implant candidates meeting the pure-tone audiometric criteria was 0.71% (n=34) among the hearing-impaired individuals (n=4758) examined in our department, whereas 2.52% (n=120) met the criteria for standard CI. Among the 34 EAS implant candidates, 2 individuals (5.83%) received EAS implant surgery after approval of the EAS device in Japan. CONCLUSIONS: There was a lower prevalence of EAS implant candidates than standard CI candidates. Nevertheless, healthcare professionals should carefully examine the audiograms of patients with high frequency hearing loss with regard to meeting the indication criteria for EAS implant. This will enable patients to gain access to adequate information relating to further examinations and treatment options.

Influence of maximum power output on speech understanding with bone anchored hearing systems.

Background: Maximum power output (MPO) levels of bone anchored hearing systems (BAHS) vary between different devices, but are significantly lower than those of conventional hearing aids, potentially limiting speech understanding.Aims/objectives: To investigate, how MPO influences speech understanding in quiet and in noise in BAHS users.Materials and methods: 12 adult BAHS users with a bilateral conductive hearing loss and additional sensorineural hearing components between 4 and 45 dB (500-4000 Hz) participated in the study. Speech understanding was measured at 65 dB in quiet and in noise with 4 different MPO level settings, covering the approximate range of MPOs found in currently available BAHS devices.Results: Speech understanding in quiet and in noise decreased with increasing sensorineural hearing loss. MPOs levels did not influence speech understanding in quiet significantly. In contrast, speech understanding in noise was better with higher MPOs (average improvement in signal-to-noise ratio +3.2 dB, p < .001), but only if the sensorineural hearing loss component was above approximately 35 dB.Conclusions and significance: At normal conversational levels, higher MPOs have little or no influence on speech understanding in quiet with BAHS. However, they can improve speech understanding in noise for users with additional sensorineural hearing loss.

Objective and subjective results of the Bonebridge transcutaneous active direct-drive bone conduction hearing implant.

OBJECTIVES: To investigate the effectiveness of a bone-anchored hearing implant system (Bonebridge implant technology) as a rehabilitation treatment for individuals with conductive or mixed hearing losses. Methods: This is a retrospective cohort study. Twelve implanted ears with conductive or mixed hearing losses were implanted with this device at a tertiary university hospital between 2012 and 2016. Audiological tests included pure tone air conduction (AC) and bone conduction (BC) measurements and unaided and aided sound-field thresholds. To evaluate the speech intelligibility in a quiet environment, the speech discrimination score (SDS) was tested using Arabic monosyllabic words, and the speech reception threshold (SRT) was measured using Arabic disyllabic words spoken in front of them. The subjective sound quality was assessed with the Hearing Implant Sound Quality Index (HISQUI). Results: In comparison with the unaided condition, there was a significant improvement in the aided thresholds, SDS, and SRT. Comparing the aided and unaided thresholds, the average AC threshold improved with an average functional gain of 40±6.3dB. The unaided SRT improved from 72.5 dB hearing levels (HL)(median) to 27.5 dB HL (median) when aided, and patients performed 71% better, on average, based on the SDS with the help of the device. The HISQUI questionnaire revealed high satisfaction with the device sound quality. Conclusion: Patients with conductive and mixed hearing loss substantially benefit from the Bonebridge active transcutaneous BC hearing implant.