Effects of Musical Training in Music Therapy Following Cochlear Implantation-A Case Report.

The most prevalent sensory impairment impacting the elderly is age-related hearing loss (HL), which affects around 65% of individuals over the age of 60 years. This bilateral, symmetrical sensorineural impairment profoundly affects auditory perception, speech discrimination, and the overall understanding of auditory signals. Influenced by diverse factors, age-related HL can substantially influence an individual's quality of life and mental health and can lead to depression. Cochlear implantation (CI) stands as a standard intervention, yet despite advancements, music perception challenges persist, which can be addressed with individualized music therapy. This case report describes the journey of an 81-year-old musician through profound sensorineural hearing loss, cochlear implantation, and rehabilitative music therapy. Auditory evaluations, musical exercises, and quality of life assessments highlighted meaningful improvements in music perception, auditory skills, and overall satisfaction post-implantation. Music therapy facilitated emotional, functional, and musical levels of engagement, notably enhancing his ability to perceive melody, rhythm, and different instruments. Moreover, subjective assessments and audiograms indicated marked improvements in auditory differentiation, music enjoyment, and overall hearing thresholds. This comprehensive approach integrating bilateral CIs and music therapy showcased audiological and quality of life enhancements in an elderly individual with profound hearing loss, emphasizing the efficacy of this combined treatment approach.

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.

Effects of Auditory Training on Speech Recognition in Children with Single-Sided Deafness and Cochlea Implants Using a Direct Streaming Device: A Pilot Study.

Treating individuals with single-sided deafness (SSD) with a cochlear implant (CI) offers significant benefits for speech perception in complex spatial listening environments. After implantation, training without involvement of the normal-hearing ear is essential. Therefore, the AudioLink streaming device (MED-EL GmbH, Austria) can be used to connect the externally worn audio processor to media devices; thus, the auditory stimuli are directly streamed to the implanted ear. The aim was to test whether children with SSD, aged 5-12 years, accept this training method and whether auditory training, streamed directly via AudioLink using the Tiptoi device (Ravensburger GmbH., Ravensburg, Germany), improves speech recognition. A total of 12 children with SSD and implanted with a CI received Tiptoi training via AudioLink and were asked to practice daily for 10 min over a period of one month. All participants completed the training. The measurements employed to assess improvement included speech audiometry, speech, spatial, and quality of hearing scale for parents (SSQ P), and specially designed tasks crafted for this study. Daily training of 9.93 min was reported. The word recognition score (WRS) at 65 dB and 80 dB in aided condition significantly improved and the WRS streamed via AudioLink was significantly better after training. The speech, spatial, and qualities of hearing scale for parents (SSQ P questionnaire) showed significant improvement in the dimension of quality of hearing and overall gain. The outcomes of the Tiptoi tasks resulted in a significant benefit in both categories of the "recognition of sounds" and "understanding of sentences". The results are very encouraging and do not only show the positive uptake of daily training at home but also how this resulted in a significant improvement in subjective and objective measures for this rather short training period of one month only.

QoL, CIs, QALYs, and Individualized Rehabilitation: The Clinical and Practical Benefits of Regularly Assessing the Quality of Life of Adult Cochlear Implant Recipients.

This study aimed to report quality of life (QoL) scores in unilateral cochlear implant (CI) users and to generate guidance for clinicians on using QoL measures to individualize CI counselling and rehabilitation and to increase access to CIs as a mode of rehabilitation. Participants (n = 101) were unilateral CI users with single-sided deafness (SSD; n = 17), asymmetrical hearing loss (AHL; n = 26), or bilateral hearing loss (Uni; n = 58). Generic QoL was assessed via the Health Utilities Index (HUI-3), and disease-specific QoL was assessed via the Speech, Spatial, and Qualities of Hearing scale (SSQ12) and Nijmegen CI Questionnaire (NCIQ) at preimplantation and at 6 and 12 months of CI use. All groups had significantly increased HUI-3 scores at both intervals. The SSD group showed significant benefit on the SSQ12 at visit 3, the AHL group showed significant benefit on the SSQ12 and most NCIQ subdomains at both intervals, and the Uni group showed significant benefit with both tests at both intervals. Unilateral CI recipients demonstrate improved QoL within the first 12 months of device use. Regular assessment with generic and disease-specific questionnaires has the potential to play an important role in personalizing treatment and possibly in increasing access to CI provision.

A Novel Representation of Audiological and Subjective Findings for Acoustical, Bone Conduction and Direct Drive Hearing Solutions.

BACKGROUND: The benefit of hearing rehabilitation is often measured using audiological tests or subjective questionnaires/interviews. It is important to consider both aspects in order to evaluate the overall benefits. Currently, there is no standardized method for reporting combined audiological and patient reported subjective outcome measures in clinical practice. Therefore, this study focuses on showing the patient's audiological, as well as subjective outcomes in one graph using data from an existing study. METHOD: The present paper illustrated a graph presenting data on four quadrants with audiological and subjective findings. These quadrants represented speech comprehension in quiet (unaided vs. aided) as WRS% at 65 dB SPL, speech recognition in noise (unaided vs. aided) as SRT dB SNR, sound field threshold (unaided vs. aided) as PTA4 in dB HL, wearing time and patient satisfaction questionnaire results. RESULTS: As an example, the HEARRING graph in this paper represented audiological and subjective datasets on a single patient level or a cohort of patients for an active bone conduction hearing implant solution. The graph offered the option to follow the user's performance in time. CONCLUSION: The HEARRING graph allowed representation of a combination of audiological measures with patient reported outcomes in one single graph, indicating the overall benefit of the intervention. In addition, the correlation and consistency between some results (e.g., aided threshold and aided WRS) can be better visualized. Those users who lacked performance benefits on one or more parameters and called for further insight could be visually identified.

Multicentric study on surgical information and early safety and performance results with the Bonebridge BCI 602: an active transcutaneous bone conduction hearing implant.

AIM: This European multicentric study aimed to prove safety and performance of the Bonebridge BCI 602 in children and adults suffering from either conductive hearing loss (CHL), mixed hearing loss (MHL), or single-sided sensorineural deafness (SSD). METHODS: 33 patients (13 adults and 10 children with either CHL or MHL and 10 patients with SSD) in three study groups were included. Patients were their own controls (single-subject repeated measures), comparing the unaided or pre-operative to the 3-month post-operative outcomes. Performance was evaluated by sound field thresholds (SF), word recognition scores (WRS) and/or speech reception thresholds in quiet (SRT) and in noise (SNR). Safety was demonstrated with a device-specific surgical questionnaire, adverse event reporting and stable pure-tone measurements. RESULTS: The Bonebridge BCI 602 significantly improved SF thresholds (+ 25.5 dB CHL/MHL/SSD), speech intelligibility in WRS (+ 68.0% CHL/MHL) and SRT in quiet (- 16.5 dB C/MHL) and in noise (- 3.51 dB SNR SSD). Air conduction (AC) and bone conduction (BC) thresholds remained stable over time. All adverse events were resolved, with none unanticipated. Mean audio processor wearing times in hours [h] per day for the CHL/MHL group were ~ 13 h for adults, ~ 11 h for paediatrics and ~ 6 h for the SSD group. The average surgical length was 57 min for the CHL/MHL group and 42 min for the SSD group. The versatility of the BCI 602 (reduced drilling depth and ability to bend the transition for optimal placement) allows for treatment of normal, pre-operated and malformed anatomies. All audiological endpoints were reached. CONCLUSIONS: The Bonebridge BCI 602 significantly improved hearing thresholds and speech understanding. Since implant placement follows the patient's anatomy instead of the shape of the device and the duration of surgery is shorter than with its predecessor, implantation is easier with the BCI 602. Performance and safety were proven for adults and children as well as for the CHL/MHL and SSD indications 3 months post-operatively.

Personalized Medicine in Otolaryngology: Special Topic Otology.

Globally, more than 1.5 billion people experience some degree of hearing loss [...].

Clinical feasibility of a novel test setup for objective measurements using the VIBRANT SOUNDBRIDGE.

Objectives: The VIBRANT SOUNDBRIDGE is a widely used active middle ear implant to treat hearing loss. The floating mass transducer is surgically coupled to the ossicles, the round or oval window. A reliable method to monitor the coupling efficiency intraoperatively is highly desired. Research groups have developed several methods, but limitations remain. This study aims to evaluate the clinical feasibility of a new research setup for auditory brainstem response measurement to evaluate the coupling efficiency. Method: In 14 subjects, the new tool was used to record VSB-evoked ABR thresholds during surgery. The intra-op ABR thresholds were compared to pre-op bone conduction (BC) thresholds and post-op vibrogram thresholds to evaluate the feasibility of the method as a tool to monitor coupling efficiency. Results: The mean pre-op BC threshold average at 1, 2, and 4 kHz (PTA3) was 47 dB HL, the mean intra-op ABR threshold was 54 dB nHL, and the mean post-op vibrogram PTA3 was 60 dB HLeq. ABR was measurable in all subjects using the new tool. Correlation between pre-op BC thresholds and intra-op ABR thresholds was statistically significant; however, one outlier was present. Conclusion: Intra-op hearing threshold detection through ABR and direct stimulation of the VSB implant was reliable using this new tool. Despite some individual variability, first results correlate well with pre-op BC and post-op vibrogram thresholds.

Suitable Electrode Choice for Robotic-Assisted Cochlear Implant Surgery: A Systematic Literature Review of Manual Electrode Insertion Adverse Events.

Background and Objective: The cochlear implant (CI) electrode insertion process is a key step in CI surgery. One of the aims of advances in robotic-assisted CI surgery (RACIS) is to realize better cochlear structure preservation and to precisely control insertion. The aim of this literature review is to gain insight into electrode selection for RACIS by acquiring a thorough knowledge of electrode insertion and related complications from classic CI surgery involving a manual electrode insertion process. Methods: A systematic electronic search of the literature was carried out using PubMed, Scopus, Cochrane, and Web of Science to find relevant literature on electrode tip fold over (ETFO), electrode scalar deviation (ESD), and electrode migration (EM) from both pre-shaped and straight electrode types. Results: A total of 82 studies that include 8,603 ears implanted with a CI, i.e., pre-shaped (4,869) and straight electrodes (3,734), were evaluated. The rate of ETFO (25 studies, 2,335 ears), ESD (39 studies, 3,073 ears), and EM (18 studies, 3,195 ears) was determined. An incidence rate (±95% CI) of 5.38% (4.4-6.6%) of ETFO, 28.6% (26.6-30.6%) of ESD, and 0.53% (0.2-1.1%) of EM is associated with pre-shaped electrodes, whereas with straight electrodes it was 0.51% (0.1-1.3%), 11% (9.2-13.0%), and 3.2% (2.5-3.95%), respectively. The differences between the pre-shaped and straight electrode types are highly significant (p < 0.001). Laboratory experiments show evidence that robotic insertions of electrodes are less traumatic than manual insertions. The influence of round window (RW) vs. cochleostomy (Coch) was not assessed. Conclusion: Considering the current electrode designs available and the reported incidence of insertion complications, the use of straight electrodes in RACIS and conventional CI surgery (and manual insertion) appears to be less traumatic to intracochlear structures compared with pre-shaped electrodes. However, EM of straight electrodes should be anticipated. RACIS has the potential to reduce these complications.

Improved Music Perception after Music Therapy following Cochlear Implantation in the Elderly Population.

BACKGROUND: Cochlear implantation (CI) and the accompanying rehabilitation has become a routine procedure in hearing restoration. Literature is sparse on elderly CI recipients focusing on the issue of age and their inclined auditory resolution, taking their diminished cognitive function into account, which requires adaptation of rehabilitation programs to overcome habituation. OBJECTIVE: This study aims to show that a few adjustments in the therapy program towards age, mental, physical and auditory condition significantly improve music perception and overall auditory benefit, hence normal communication and social interactions can be found. METHODS: Subjects implanted with a CI 65 years or older were compared to age-matched normal hearing subjects. Questionnaires were administered before and after ten music therapy sessions, to evaluate the participant's music habits, the perception of sound quality and self-awareness and hearing implant satisfaction. RESULTS: The greatest benefit was seen in participants' gain in self-confidence and enjoyable music perception. Not only did the amount of listening to music increase, but also the impression of sound quality changed from poor up to good/very good sound quality. CONCLUSIONS: The music therapy was well accepted and resulted in beneficial subjective as well as objective outcomes towards hearing and music impression, hence improved quality of life.

Using Generic and Disease-Specific Measures to Assess Quality of Life before and after 12 Months of Hearing Implant Use: A Prospective, Longitudinal, Multicenter, Observational Clinical Study.

The primary objectives of this study were to evaluate the effect of hearing implant (HI) use on quality of life (QoL) and to determine which QoL measure(s) quantify QoL with greater sensitivity in users of different types of HIs. Participants were adult cochlear implant (CI), active middle ear implant (VIBRANT SOUNDBRIDGE (VSB)), or active transcutaneous bone conduction implant (the BONEBRIDGE (BB)) recipients. Generic QoL and disease-specific QoL were assessed at three intervals: pre-activation, 6 months of device use, and 12 months of device use. 169 participants completed the study (110 CI, 18VSB, and 41BB). CI users' QoL significantly increased from 0-6 m device use on both the generic- and the disease-specific measures. On some device-specific measures, their QoL also significantly increased between 6 and 12 m device use. VSB users' QoL significantly increased between all tested intervals with the disease-specific measure but not the generic measure. BB users' QoL significantly increased from 0-6 m device use on both the generic- and the disease-specific measures. In sum, HI users experienced significant postoperative increases in QoL within their first 12 m of device use, especially when disease-specific measures were used. Disease-specific QoL measures appeared to be more sensitive than their generic counterparts.

Long-Term Safety and Quality of Life after Vibroplasty in Sensorineural Hearing Loss: Short/Long Incus Process Coupler.

OBJECTIVE: The study shows the long-term effectiveness, safety, and quality of life after Vibrant Soundbridge (VSB) implantation in sensorineural hearing loss (SNHL) using the short process coupler (SP) or the long process coupler (LP). METHODS: This retrospective study evaluated 77 VSB cases. Follow-up (F/U) time-dependent objective measurements (audiological outcomes), subjective data collection (quality-of-life questionnaire), and safety measures are presented. RESULTS: Sixty-two ears were included in the analysis with up to 116 months of postsurgical F/U data (mean 32.15 ± 37.97 months LP and SP coupler). Fifty-three ears (13 bilateral cases) received the LP coupler and 9 subjects the SP coupler. The post-operative bone conduction thresholds remained stable and, in both groups, <10 dB. The benefit in word recognition scores measured at 65 dB SPL and 80 dB SPL showed no significant difference between the couplers (p = 0.559 and p = 0.088, respectively). The functional gain was not significantly different (p > 0.05) with a mean of 20.91 ± 9.77 and 17.19 ± 5.75 for LP and SP coupler, respectively. The utility score deciphered from the Assessment of Quality-of-life Questionnaire-8 dimensions revealed a mean score of 0.75 ± 0.16 which is not significantly different to the age- and sex-matched healthy control group with 0.81 ± 0.02 (p = 0.3547). CONCLUSION: The Incus Vibroplasty utilizing both couplers is a safe and effective method to treat mild-to-severe SNHL. Both fixation methods of the floating mass transducer exhibit good clinical and audiological outcomes with high patient quality of life. The SP coupling method can be a good alternative when the long process is anatomically inaccessible, or the approach is limited due to anatomical reasons.

Surgical Experience and Early Audiological Outcomes With New Active Transcutaneous Bone Conduction Implant.

OBJECTIVES: Our objective was to report the very first surgical experiences, audiologic benefits, and satisfaction with the new active transcutaneous bone conduction implant, generation 602 (BCI602), in patients with mixed/conductive hearing loss (M/CHL) and single-sided deafness. METHODS: A retrospective chart review from patients who underwent BCI602 surgery was performed. RESULTS: Twelve subjects were implanted (mean age 33.17 ±â€Š21.67 yrs). Mean surgery time was 29.89 ±â€Š8.59 minutes, with the longest being a difficult passive-BCI explantation due to excessive osseointegration. No surgical nor post-surgical complications occurred. No pre-operative surgical planning for device placement was necessary, no BCI-lifts were used and complete transmastoid implantation was possible. The mean functional gain in the M/CHL cohort significantly increased after 3 months (ρ < .0001). The mean word recognition score (%) in quiet for the M/CHL group significantly improved at activation and 3 months post-surgery (ρ = .0002; ρ < .0001). At the 3 months follow-up the subjects reported high satisfaction with the device accompanied with a mean wearing time of 10.13 hours per day (range 18-6 h/d) resulting in a reported battery change of every 8.29 ±â€Š0.49 days. CONCLUSIONS: These early results of the new BCI602 showed significantly improved audiological performance, no limitations during surgery (youngest subject 2 yrs at surgery), no prior surgical planning necessary, accompanied by high patient satisfaction and increased wearing time. Based on these results, the BCI602 can be highly recommended and especially for difficult anatomical and surgical cases and the given indication for children older than 5 years should probably be revaluated.Level of Evidence: Level 4.

Long-Term, Multicenter Results With the First Transcutaneous Bone Conduction Implant.

OBJECTIVE: Investigation of long-term safety and performance of an active, transcutaneous bone conduction implant in adults and children up to 36 months post-implantation. STUDY DESIGN: Prospective, single-subject repeated-measures design. SETTING: Otolaryngology departments of eight German and Austrian hospitals.∗†‡§||¶#∗∗†† Affiliations listed above that did not participate in the study.‡‡§§||||¶¶. PATIENTS: Fifty seven German-speaking patients (49 adults and eight children) suffering from conductive or mixed hearing loss, with an upper bone conduction threshold limit of 45 dB HL at frequencies between 500 and 3000 Hz. INTERVENTION: Implantation of the Bonebridge transcutaneous bone conduction hearing implant (tBCI). MAIN OUTCOME MEASURES: Patients' audiometric pure tone averages (PTA4) (0.5, 1, 2, 4 kHz) thresholds (air conduction, bone conduction, and sound field) and speech perception (word recognition scores [WRS] and speech reception thresholds [SRT50%]) were tested preoperatively and up to 36 months postoperatively. Patients were also monitored for adverse events and administered quality-of-life questionnaires. RESULTS: Speech perception (WRS: pre-op: 17.60%, initial activation [IA]: 74.23%, 3M: 83.65%, 12M: 83.46%, 24M: 84.23%, 36M: 84.42%; SRT50%: pre-op: 65.56 dB SPL, IA: 47.67 dB SPL, 3M: 42.61 dB SPL, 12M: 41.11 dB SPL, 24M: 41.74 dB SPL, 36M: 42.43 dB SPL) and sound field thresholds (pre-op: 57.66 dB HL, IA: 33.82 dB HL, 3M: 29.86 dB HL, 12M: 28.40 dB HL, 24M: 28.22 dB HL, 36M: 28.52 dB HL) improved significantly at all aided postoperative visits. Air and bone conduction thresholds showed no significant changes, confirming preservation of patients' residual unaided hearing. All adverse events were resolved by the end of the study. CONCLUSIONS: Safety and performance of the tBCI was demonstrated in children and adults 36 months postoperatively.

Long-Term Stability and Safety of the Soundbridge Coupled to the Round Window.

OBJECTIVE: The objective of the study was to demonstrate the long-term outcomes of patients implanted with the active middle ear implant (AMEI) Vibrant Soundbridge (VSB) through coupling the floating mass transducer (FMT) to the round window (RW). METHODS: This retrospective study evaluated the short- and long-term clinical performance (audiological outcomes) and safety (revisions/explantations) of the VSB coupled to the RW between 2013 and 2019 at the St. Pölten University Hospital, Austria. For the outcome analysis, the sample was divided into a short-term examination group followed up for less than 12 months (<12 months) and a long-term examination group followed up for more than 12 months (>12 months). Cumulative survival outcomes were separately analyzed for subjects with and without cholesteatoma. RESULTS: 46 patients with an average long-term follow-up period of 31.43 months (13-75 months) were investigated. Complications requiring revision surgery were reported in total in seven patients with cholesteatoma (15.2%) and none in subjects without cholesteatoma (0%). Residual hearing was not affected by VSB surgery. Word understanding on the Freiburger monosyllabic speech test improved significantly at 65 dB (P < .0001) and 80 dB (P < .0001), and these outcomes were stable for long-term follow up. CONCLUSION: The VSB coupled to the RW is a safe implantation method for patients with conductive or mixed hearing loss. Hearing improvement was stable for the long-term follow-up up to 74 months. The revision rates are directly related to the underlying pathology of cholesteatoma (with radical cavity); thus, this special cohort requires additional counseling on potential complications. LEVEL OF EVIDENCE: 4 (Case-series) Laryngoscope, 131:E1434-E1442, 2021.

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.

Long-term Hearing Preservation in Electric Acoustic Cochlear Implant Candidates.

OBJECTIVES: To evaluate long-term stability and residual hearing preservation after cochlear implantation with electric acoustic stimulation (EAS). STUDY DESIGN: Retrospective chart-analysis. SETTING: University clinic. METHODS: Long- and short-term hearing preservation (HP) of 18 EAS subjects (21 ears) was evaluated. Short-term was defined as follow-ups less than 12 months after surgery versus long-term outcomes longer than 12 months postsurgery. RESULTS: Mean period of observation in the short-term group was 4 ±â€Š3.0 months (range 0-7). In the long-term group the mean follow-up was 28.4 ±â€Š15.0 months (range 12-58). Full insertion was possible in all 18 implanted subjects. In the short-term group, complete HP was achieved in 50%, partial HP in 33.3%, and minimal HP in 8.3% of the investigated subjects. One subject lost hearing completely. In the long-term group, complete HP was achieved in 50%, partial HP was observed in 40%, and minimal HP in 10% of the ears. No subject lost hearing completely. Subjects using EAS showed better word recognition scores after surgery (mean at 65 dB 55.3 ±â€Š18.4; mean at 80 dB 68.1 ±â€Š12.2) than subjects using electric stimulation only (mean at 65 dB 38.3 ±â€Š18.1; mean at 80 dB 60.0 ±â€Š16.4) with nonfunctional low-frequency hearing. CONCLUSION: The study confirms that hearing can be preserved to a large extent. As a result, most subjects benefitted from EAS. Subjects with postoperative functional low-frequency hearing showed greater benefit in word speech tests. Furthermore, the outcomes show that EAS implantation is a safe, effective, and most importantly stable treatment option (longest follow-up with 58 mo).

Active transcutaneous bone conduction hearing implants: Systematic review and meta-analysis.

BACKGROUND: In July 2018 the active transcutaneous bone conduction hearing implant received FDA approval in the US (for patients 12 years and older with conductive and/or mixed hearing loss or single-sided deafness), reflecting the current trend of moving away from percutaneous hearing solutions towards intact skin systems. OBJECTIVES: To critically assess the current literature on safety, efficacy and subjective benefit after implantation with an active transcutaneous bone conduction hearing device. DATA SOURCES: Literature investigation was performed by electronic database search including PubMed and Cochrane Central Register of Controlled Trials, and manual search of relevant journals and reference lists of included studies. STUDY ELIGIBILITY CRITERIA: Randomized controlled trials, clinical controlled trials and cohort studies, case series and case reports investigating subjective and objective outcomes. STUDY APPRAISAL AND SYNTHESIS METHODS: Retrieved literature was screened and extracted by two reviewers independently. Subgroup analysis of indications (conductive and/or mixed hearing loss, single-sided deafness) and participant ages (pediatric vs. adults) was conducted on patients with active transcutaneous bone conduction devices. Sensitivity analysis was performed to test the stability of the results in meta-analysis. RESULTS: 39 citations reporting on pre- and postoperative audiological results, speech performance in quiet and in noise, localization testing as well as subjective outcomes were included in this systematic review. Functional gain as well as word recognition score outcomes could be further investigated via meta-analysis. All outcomes reported and summarized here reflect beneficial audiological performance and high patient satisfaction, accompanied with a low complications rate (minor event incidence rate: 9.9 person-years; major incidence rate: 148.9 person-years) for the indications of conductive and mixed hearing loss as well as in individuals suffering from single-sided deafness for all age groups of subjects who underwent active transcutaneous bone conduction hearing device implantation. LIMITATIONS: A limiting factor of this systematic review was the Level of Evidence of the reviewed literature, comprising 2a/3a studies (cohort studies and case-control studies). Furthermore, the reporting standards, especially in outcomes such as word recognition scores in quiet and in noise, vary across study cites from various countries, which impedes comparisons. Last but not least, no other comparable other device was retrieved as the active transcutaneous bone conduction hearing device is the only available at the moment. CONCLUSION: The device's transcutaneous technology results in a minor event incidence rate of one in 9.9 person-years and a major incidence rate of one in 148.9 person-years. Based on the audiological outcomes, high patient satisfaction as well as the low complication rate, the authors recommend the active transcutaneous bone conduction hearing device as a safe and effective treatment for patients suffering from hearing loss within the device's indication criteria (conductive and/or mixed hearing loss or single-sided deafness).

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.

Minimal Reporting Standards for Active Middle Ear Hearing Implants.

There is currently no standardized method for reporting audiological, surgical and subjective outcome measures in clinical trials with active middle ear implants (AMEIs). It is often difficult to compare studies due to data incompatibility and to perform meta-analyses across different centres is almost impossible. A committee of ENT and audiological experts from Germany, Austria and Switzerland decided to address this issue by developing new minimal standards for reporting the outcomes of AMEI clinical trials. The consensus presented here aims to provide a recommendation to enable better inter-study comparability.