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.

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.

Successful hearing improvement with direct acoustic stimulation in a patient with schizophrenia.

OBJECTIVE: A direct acoustic cochlear implant provides its power directly to the inner ear by vibrating the perilymph via a conventional stapes prosthesis. Our experience with a patient with severe mixed hearing loss due to otosclerosis is described.Case reportThe patient, a 47-year-old male, had a pre-operative speech recognition score of 10 per cent and had been treated for many years for schizophrenia, both of which made him a poor candidate for a direct acoustic stimulation device. Nevertheless, the surgery was performed, which preserved the pre-operative bone conduction level and significantly improved hearing. His speech recognition score rose to 100 per cent. He uses the device all day and his auditory hallucinations have subsided. Improvement of schizophrenia symptoms has enabled the patient to reduce his psychiatric medications intake. CONCLUSION: Hearing restoration was the main reason for the reduction of auditory hallucinations in our patient. Hearing loss is a potentially reversible risk factor for psychosis, but this association is often overlooked.

Does hearing in response to soft-tissue stimulation involve skull vibrations? A within-subject comparison between skull vibration magnitudes and hearing thresholds.

Hearing can be elicited in response to bone as well as soft-tissue stimulation. However, the underlying mechanism of soft-tissue stimulation is under debate. It has been hypothesized that if skull vibrations were the underlying mechanism of hearing in response to soft-tissue stimulation, then skull vibrations would be associated with hearing thresholds. However, if skull vibrations were not associated with hearing thresholds, an alternative mechanism is involved. In the present study, both skull vibrations and hearing thresholds were assessed in the same participants in response to bone (mastoid) and soft-tissue (neck) stimulation. The experimental group included five hearing-impaired adults in whom a bone-anchored hearing aid was implanted due to conductive or mixed hearing loss. Because the implant is exposed above the skin and has become an integral part of the temporal bone, vibration of the implant represented skull vibrations. To ensure that middle-ear pathologies of the experimental group did not affect overall results, hearing thresholds were also obtained in 10 participants with normal hearing in response to stimulation at the same sites. We found that the magnitude of the bone vibrations initiated by the stimulation at the two sites (neck and mastoid) detected by the laser Doppler vibrometer on the bone-anchored implant were linearly related to stimulus intensity. It was therefore possible to extrapolate the vibration magnitudes at low-intensity stimulation, where poor signal-to-noise ratio limited actual recordings. It was found that the vibration magnitude differences (between soft-tissue and bone stimulation) were not different than the hearing threshold differences at the tested frequencies. Results of the present study suggest that bone vibration magnitude differences can adequately explain hearing threshold differences and are likely to be responsible for the hearing sensation. Thus, the present results support the idea that bone and soft-tissue conduction could share the same underlying mechanism, namely the induction of bone vibrations. Studies with the present methodology should be continued in future work in order to obtain further insight into the underlying mechanism of activation of the hearing system.

A comparative study of MED-EL FMT attachment to the long process of the incus in intact middle ears and its attachment to disarticulated stapes head.

The Vibrant Soundbridge© (VSB) active middle-ear implant provides an effective treatment for mild-to-severe sensorineural hearing loss in the case of normal middle ear anatomy and mixed hearing loss in middle ear malformation. The VSB floating mass transducer (FMT), with proper couplers, can be installed on various structures of the ossicular chain, e.g., the short and long process of the incus, the stapes head, and the stapes footplate. A long process (LP) coupler is most commonly used for FMT attachment to the long process of the incus with intact ossicular chain, while CliP and Bell couplers are two standardized and reliable methods for FMT attachment to the stapes head with missing incus and malleus. However, the difference and relationship of the vibration properties among these three FMT couplers remain unclear. In the present study, the stapes footplate velocity responses of the LP, CliP, and Bell couplers have been investigated in eight fresh temporal bones (TBs) to evaluate the vibration properties of these three couplers. Normal and reconstructed middle ear transfer functions (METFs) were determined from laser Doppler vibrometer (LDV) measurements. A mastoidectomy and a posterior tympanotomy were performed to expose the ossicular chain. The METFs of the normal middle ear and middle ear with LP-FMT-coupler were compared under acoustic stimulation, thus the mass effect of the FMT with LP coupler was evaluated. Additional comparisons were made between the stapes footplate vibrations of the LP-FMT-coupler (with the intact ossicular chain at the long process of the incus), CliP-FMT-coupler and Bell-FMT-coupler on the stapes head (after incus and malleus removed) under active electromechanical stimulation. After the installation of CliP-FMT-coupler and Bell-FMT-coupler to the middle ear, the average velocity amplitude of the stapes footplate, comparing to the LP-FMT-coupler, was about 15 dB higher between 1 and 6 kHz, and 10 dB lower at about 0.5 kHz. Quantitatively, there was no significant difference between the CliP-FMT-coupler and Bell-FMT-coupler. According to our study, installation of CliP-FMT-coupler or Bell-FMT-coupler on the stapes head provides considerable improvement of the middle ear mechanical and functional responses, comparing with the LP-FMT-coupler in the temporal bone experiments. Moreover, the installation of the Bell-FMT-coupler to the stapes head produces essentially the same footplate velocity responses in comparison to the CliP-FMT-coupler.

Retrospective audiological analysis of bone conduction versus round window vibratory stimulation in patients with mixed hearing loss.

OBJECTIVE: To compare audiological outcomes in mild-to-moderate mixed hearing loss patients treated with a bone-anchored hearing aid or an active middle-ear implant. Analysis aimed to refine criteria used in preoperative selection of implant type. DESIGN: Retrospective comparative analysis of audiological data. Follow-up time ranged between 0.55 and 8.8 years. STUDY SAMPLE: For detailed comparative analysis, 12 patients (six in each group) with comparable bone conduction thresholds and similar clinical characteristics were selected. A larger cohort of 48 patient files were used to evaluate overall audiological indication criteria (24 per group). RESULTS: In free-field tone audiometry, Baha patients showed mean aided thresholds between 40-48 dB, whereas hearing thresholds for VSB patients were 25-43 dB. Baha and VSB users had mean WRS of 56% and 82%, respectively, at 65 dB. Better speech understanding in noise was seen with the VSB. CONCLUSION: Analysis of the main cohort (n = 48) showed that treatment with round window vibroplasty leads to better hearing performance than treatment with a bone-anchored hearing device, if the bone conduction pure-tone average (0.5 to 4 kHz) is poorer than 35 dB HL. Audiological analysis in the smaller comparative analysis showed similar findings.

The bone conduction implant: Clinical results of the first six patients.

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.

Wireless and acoustic hearing with bone-anchored hearing devices.

OBJECTIVE: The efficacy of wireless connectivity in bone-anchored hearing was studied by comparing the wireless and acoustic performance of the Ponto Plus sound processor from Oticon Medical relative to the acoustic performance of its predecessor, the Ponto Pro. STUDY SAMPLE: Nineteen subjects with more than two years' experience with a bone-anchored hearing device were included. Thirteen subjects were fitted unilaterally and six bilaterally. DESIGN: Subjects served as their own control. First, subjects were tested with the Ponto Pro processor. After a four-week acclimatization period performance the Ponto Plus processor was measured. In the laboratory wireless and acoustic input levels were made equal. In daily life equal settings of wireless and acoustic input were used when watching TV, however when using the telephone the acoustic input was reduced by 9 dB relative to the wireless input. RESULTS: Speech scores for microphone with Ponto Pro and for both input modes of the Ponto Plus processor were essentially equal when equal input levels of wireless and microphone inputs were used. Only the TV-condition showed a statistically significant (p <5%) lower speech reception threshold for wireless relative to microphone input. In real life, evaluation of speech quality, speech intelligibility in quiet and noise, and annoyance by ambient noise, when using landline phone, mobile telephone, and watching TV showed a clear preference (p <1%) for the Ponto Plus system with streamer over the microphone input. Due to the small number of respondents with landline phone (N = 7) the result for noise annoyance was only significant at the 5% level. CONCLUSION: Equal input levels for acoustic and wireless inputs results in equal speech scores, showing a (near) equivalence for acoustic and wireless sound transmission with Ponto Pro and Ponto Plus. The default 9-dB difference between microphone and wireless input when using the telephone results in a substantial wireless benefit when using the telephone. The preference of wirelessly transmitted audio when watching TV can be attributed to the relatively poor sound quality of backward facing loudspeakers in flat screen TVs. The ratio of wireless and acoustic input can be easily set to the user's preference with the streamer's volume control.

Transient and steady state auditory responses with direct acoustic cochlear stimulation.

OBJECTIVES: Direct acoustic cochlear implants directly stimulate the cochlear fluid of the inner ear by means of a stapes piston driven by an actuator and show encouraging speech understanding in noise results for patients with severe to profound mixed hearing loss. Auditory evoked potentials recorded in such patients would allow for the objective evaluation of the aided auditory pathway. The aim of this study was (1) to develop a stimulation setup for EEG recordings in subjects with direct acoustic cochlear implants, (2) to show the feasibility of recording auditory brainstem responses (ABRs) and auditory steady state responses (ASSRs), and (3) to analyze the relation between electrophysiological thresholds derived from these responses and behavioral thresholds. DESIGN: For the three subjects implanted during a phase Ib clinical study in the authors' center, ABRs and 40 and 80 Hz ASSRs were recorded with a straightforward acoustic stimulation setup and a newly developed direct stimulation setup. Click trains with rates around 40 Hz and around 90 Hz were used as stimuli. By comparing amplitude growth function and phase delay in the same stimulus range, validity of the responses was confirmed. RESULTS: With the acoustic stimulation setup, stimulation artifacts made it impossible to analyze responses. With the direct stimulation setup, stimulation artifacts could be removed completely and responses could be successfully recorded in a noninvasive manner in all subjects. Response properties such as ABR peak V latencies and ASSR apparent latencies were similar to those for acoustic stimulation, with apparent latencies of 39.9 and 24.7 msec for 40 and 90 Hz, respectively. Electrophysiological thresholds could be objectively determined from the ABRs and ASSRs. In the 40 Hz range, the mean difference between electrophysiological ASSR thresholds and behavioral ones was 12 dB. CONCLUSION: The results show that auditory evoked potential measurements with the developed direct stimulation setup are feasible and meaningful and should be further investigated to provide intraoperative feedback about the coupling of the actuator to the inner ear.