Subjective Hearing Impression and Quality of Life in Patients With Bilateral Active Middle Ear Implants.

OBJECTIVE: This study compared the quality of life in patients with bilateral active middle ear implants to their quality of life when they were unilaterally implanted. DESIGN: Twenty-one patients implanted sequentially with the Vibrant Soundbridge (VSB) active middle ear implant completed quality-of-life surveys. The patients were asked to rate whether and to what extent their quality of life has changed upon receiving a second VSB. Hearing-specific quality of life was assessed with the Speech, Spatial, and Qualities of Hearing Scale (SSQ12-B), and general quality of life was with the Glasgow Benefit Inventory (GBI). In addition, the patients completed a health-related quality-of-life questionnaire (AQoL-8D). Finally, the changes in hearing-related and general quality of life were correlated to the change in word recognition ability after implantation of the second VSB (Freiburg monosyllabic word test; unilateral VSB versus bilateral VSB at 65 dB SPL). RESULTS: On the SSQ12, subjects scored a median of + 2.73 (p < 0.001; significantly different from zero) on a scale of -5 to + 5 where 0 indicates no change. All three subscores showed significant improvement. On the GBI, patients reached a median overall score of + 23.6 (p < 0.001; significantly different from zero) on a scale of -100 to + 100 where 0 indicates no change. Here, the improvement was mainly visible in the general subscore, whereas the social support and physical health subscores did not change due to the intervention. Both subjective benefit rating scores strongly correlated with the change in word recognition scores, suggesting that both hearing and general quality of life improved with increased word recognition due to bilateral VSB use. No significant correlation was found between the subjects' general health (as measured by AQoL-8D utility scores) and SSQ12-B or GBI overall scores. CONCLUSION: Usage of a second active middle ear implant substantially improved our patients' subjective hearing and general quality of life compared with unilateral use. The increase in quality of life may be linked to improved speech understanding due to bilateral use of a middle ear implant. Furthermore, these outcomes were not influenced by our patients' general health state at the time of survey.

A Transcutaneous Active Middle Ear Implant (AMEI) in Children and Adolescents: Long-term, Multicenter Results.

OBJECTIVE: Evaluation of the long-term safety and performance of an active middle ear implant (AMEI) in the treatment of hearing loss in children and adolescents with a primary focus on improvement in speech discrimination. STUDY DESIGN: Prospective, multicentric, single-subject repeated-measures design in which each subject serves as his or her own control. SUBJECTS: Thirty-one pediatric subjects aged 5 to 17 years. INTERVENTION: Implantation of an active middle ear implant. METHODS: Improvement in word recognition scores, speech reception thresholds (SRT) in quiet and noise, in addition to air conduction, bone conduction, and sound field thresholds were evaluated in two age groups. RESULTS: Residual hearing did not change over time and speech intelligibility significantly improved and remained stable after 36 months. Children aged 5 to 9 improved in WRS from 21.92 to 95.38% and in SRT in quiet and in noise respectively from 62.45 dB SPL (sound pressure level) and +1.14 dB SNR to 42.07 dB SPL and -4.45 dB SNR. Adolescents aged 10 to 17 improved in WRS from 12.78 to 84.71% and in SRT in quiet and in noise respectively from 63.96 dB SPL and +3.32 dB SNR to 35.31 dB SPL and -4.55 dB SNR. CONCLUSIONS: The AMEI, under investigation, is a safe treatment for children and adolescents, and significantly improved audiological performance that remains stable on the long-term scale (up to 36 mo postimplantation). In general, all adult-related issues and questions regarding safety and performance can also be applied to the pediatric population, as no apparent specific issues developed.

Modified-Power-Piston: Short-Incudial-Process-Vibroplasty and Simultaneous Stapedotomy in Otosclerosis.

OBJECTIVE: If mixed-hearing-loss (MHL) occurs in otosclerosis, hearing-aids (HA) in addition to conventional-stapedotomy (SDT) may be necessary. If otosclerosis progresses or technical or medical problems prevent use of HA, combining active-middle-ear-implants (AMEI) with SDT ("power-piston") may be considered. Previously, AMEI-coupling to the long-incudial-process was suggested. Here, a "modified-power-piston" surgery (mPP) coupling to the short-incudial-process was proposed, so no coupling over the positioned stapes-piston is required. We questioned whether mPP is as safe and effective as SDT. METHODS: Otosclerotic patients with MHL and limited satisfaction with previously worn HA receiving mPP were retrospectively reviewed at two Austrian tertiary otologic referral centers. Patients, receiving stapedotomy, were case-matched for preoperative pure-tone averages (PTA), bone-conduction (BC-PTA), air-conduction (AC-PTA), and air-bone gap (ABG-PTA). Postoperative changes in BC-PTA and in AC-PTA and ABG-PTA were defined as safety- and as efficacy outcome parameter. RESULTS: Of 160 patients, 14 received mPP and 14 stapedotomy. Preoperative findings were comparable (all p = 1.000). BC-PTA improved from 38.0 to 36.7 and from 37.1 to 36.9 dB-HL for mPP and SDT, respectively (Δ -1.3 versus -0.2 dB-HL; p = 0.077). AC-PTA improved from 66.8 to 47.1 and from 66.3 to 46.5 dB-HL for mPP and SDT, respectively (Δ -19.6 versus -19.7 dB-HL; p = 0.991). ABG-PTA improved from 28.8 to 10.4 and from 29.1 to 9.6 dB-HL for mPP and SDT, respectively (Δ -18.3 versus -19.5 dB-HL; p = 0.771). CONCLUSION: In otosclerosis with MHL and limited satisfaction with HA, mPP appeared as safe and effective as SDT and may be considered a treatment alternative in these patients.

Improvement of sound source localization abilities in patients bilaterally supplied with active middle ear implants.

CONCLUSIONS: Patients, who are bilaterally supplied with active middle ear implants, perform slightly better in sound localization tasks than when unilaterally aided or unaided. OBJECTIVES: To investigate the impact of bilateral use of active middle ear implants on sound source localization in the horizontal plane in patients with a sloping moderate-to-severe hearing loss. METHODS: Ten adults supplied with Med-EL Vibrant Soundbridge systems (VSB) in both ears participated in the study. Four listening conditions were tested: unaided, aided with VSB on left or right ear and on both sides. In each condition the subjects had to judge the direction of broadband noises delivered randomly across a semicircular array of 11 loudspeakers arranged in an anechoic chamber. RESULTS: When unaided or bilaterally aided, the subjects localized on average 40% of the stimuli correct; when unilaterally aided (left or right), this rate dropped to 20-30% in either condition. Precision of sound localization was highest when bilaterally aided, i.e. the mean RMS angular error was 10°, and lowest when unilaterally aided, i.e. 15°. This is in line with bilateral hearing aid users, who show similar performance in sound localization tasks.

A New Transcutaneous Bone Conduction Hearing Implant: Short-term Safety and Efficacy in Children.

OBJECTIVE: To investigate the safety and efficacy of a new bone conduction hearing implant in children, during a 3-month follow-up period. STUDY DESIGN: Prospective, single-subject repeated-measures design in which each subject serves as his/her own control. SETTING: Otolaryngology departments of four Austrian hospitals. PATIENTS: Twelve German-speaking children aged 5 to 17 suffering from conductive or mixed hearing loss, with an upper bone conduction threshold limit of 45 dB HL at frequencies between 500 and 4000 Hz. INTERVENTION: Implantation of the Bonebridge transcutaneous bone conduction hearing implant (tBCI). MAIN OUTCOME MEASURES: The subjects' audiometric thresholds (air conduction, bone conduction, and sound field at frequencies 500 Hz to 8 kHz) and speech perception (word recognition scores [WRS] and 50% word intelligibility in sentences [SRT50%]) were tested preoperatively and at 1 and 3 months postoperatively. The patients were also monitored for adverse events and they or their parents filled out questionnaires to analyze satisfaction levels. RESULTS: Speech perception as measured by WRS and SRT50% improved on average approximately 67.6% and 27.5 dB, respectively, 3 months after implantation. Aided thresholds also improved postoperatively, showing statistical significance at all tested frequencies. Air conduction and bone conduction thresholds showed no significant changes, confirming that subjects' residual unaided hearing was not damaged by the treatment. Only minor adverse events were reported and resolved by the end of the study. CONCLUSION: Safety and efficacy of the new bone conduction implant was demonstrated in children followed up to 3 months postoperatively.

Bilateral use of active middle ear implants: speech discrimination results in noise.

Binaural sound reception has advantages over unilateral perception, including better localization and sound quality as well as speech and tone reception in both quiet and noisy environments. Up to now, most active middle ear implant (AMEI) users have been unilaterally implanted, but patient demand for an implant on the other side is increasing. Ten bilaterally-AMEI implanted native German-speaking adults were included in the study. The Oldenburg sentence test was used to measure speech reception thresholds in noise. The subject's signal-to-noise ratio (SNR) at a speech reception score of 50 % was calculated for different noise conditions. SRT was measured as a function of noise condition (nc) and listening condition (lc)-for example, SRT (lc, nc), with nc from S0N0, S0N-90, or S0N90 and lc from left, right or both. For each noise condition, the squelch effect and the binaural summation effect were calculated. Patients in this study demonstrated improvement with bilateral AMEIs compared to right or left AMEI only in all three tested listening conditions. Statistical significance was found in the S0N0 condition to favor usage of bilateral AMI versus either the right or left side only. The benefits of binaural hearing are well known, also in normal-hearing individuals. In the future every bilateral implantation should be a part of the clinical routine. Bilateral implantation can help to reduce problems in background noise and restore directional hearing.

Active middle ear implantation in elderly people: a retrospective study.

OBJECTIVE: To evaluate the outcomes of younger (<60 yr) and older (≥60 yr) patients implanted with the Vibrant Soundbridge (VSB). The aim was to determine if there were differences between groups. METHOD: A retrospective study was used to evaluate all patients who were implanted and fit with a VSB during 2008 and 2009 at the Department of Otorhinolaryngology-Head and Neck Surgery, Medical University Innsbruck. Differences in audiologic, medical, and surgical outcomes between younger and older patients were evaluated. RESULTS: No patients had major complications during or after the surgical procedure. All patients had a good hearing benefit as supported by improvements in hearing thresholds from the preoperative to the postoperative condition in the sound field. There were differences between groups in speech understanding postoperatively; however, the differences were not statistically significant. CONCLUSION: All patients had, independent of age, good audiologic benefit from VSB use. Based on the low risk of medical or surgical complications, the easy use of the hearing implant, audiologic improvements, and potential social benefits, we think that the VSB should be regularly offered to adults with hearing loss, whether they are young or old.