Evaluation of the Baha SoundArc in children.

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

Results of a Novel, Nonsurgical Bone-Conduction Hearing Aid for the Treatment of Conductive Hearing Loss in Australian Children.

OBJECTIVE: To determine and compare the benefits a novel adhesive bone-conduction system and a conventional bone-conduction hearing aid (BCHA) on a softband for children with conductive hearing loss. STUDY DESIGN: Prospective, single-subject randomized, crossover trial. SETTING: Tertiary referral center in Australia. PARTICIPANTS: Eight children aged from 4 to 17 years with conductive hearing loss. INTERVENTION: Rehabilitative with participants using the novel adhesive bone-conduction aid and a BCHA. MAIN OUTCOME MEASURES: Aided thresholds, as well as speech perception in quiet, unaided and aided with the novel adhesive bone-conduction aid and BCHA on a softband. For the six older children, speech in noise testing was also conducted. RESULTS: The mean unaided four frequency average hearing levels was 48 dB HL for air conduction, 10.5 dB HL for bone conduction, with a mean air-bone gap in the aided ear of 37.5 dB HL.Four-frequency average hearing level aided thresholds were 20.2 dB for the novel device and 19.8 dB for the BCHA, with no significant difference between the devices. Aided monosyllabic word scores improved from an average of 45% in the unaided condition to 81.6 and 85% for the novel adhesive and BCHA devices, respectively. Aided speech in noise performance improved, on average, by 1.6 dB SNR when wearing the BCHA and the novel adhesive device, with no significant difference in performance between the two devices. CONCLUSIONS: The novel device provided equivalent performance to the BCHA on all measures and can be considered as an alternative device for pediatric patients with conductive hearing loss.

Ten years' experience with bone conduction hearing aids in the Western Cape, South Africa.

Untreated conductive and mixed hearing losses as a result of middle ear pathology or congenital ear malformations can lead to poor speech, language and academic outcomes in children. Lack of access to centralised hearing healthcare in resource-constrained environments limits opportunities for children with hearing loss. Red Cross War Memorial Children's Hospital (RCWMCH) is one of only two dedicated paediatric hospitals in sub-Saharan Africa. Between 2016 and 2021, 29 children received implanted bone conduction hearing devices, and 104 children were fitted with bone conduction devices on softbands. The authors' experience at RCWMCH suggests that bone-anchored hearing devices, either fitted on softbands or on implanted abutments, can provide solutions in settings where patients have limited access to hearing healthcare and optimal classroom environments. Hearing healthcare should be accessible and delivered at the appropriate level of care to mitigate the adverse effects of hearing loss in children.Contribution: This article describes strategies employed at RCWMCH such as fitting bone conduction hearing devices on a softband immediately after hearing loss diagnosis and conducting follow-up via remote technology to make hearing healthcare more accessible to vulnerable populations.

Clinical consensus document for fitting non-surgical transcutaneous bone conduction hearing devices to children.

This clinical consensus document addresses the assessment, selection, and fitting considerations for non-surgical bone conduction hearing devices (BCHD) for children under the age of 5 years identified as having unilateral or bilateral, permanent conductive or mixed hearing losses. Children with profound unilateral sensorineural hearing losses are not addressed. The document was developed based on evidence review and consensus by The Paediatric Bone Conduction Working Group, which is composed of audiologists from North America who have experience working with BCHDs in children. The document aims to provide clinical direction for an area of paediatric audiology practice that is under development and is therefore lacking in standard protocols or guidelines. This work may serve as a basis for future research and clinical contributions to support prospective paediatric audiology practices.

Effects of rapid maxillary expansion on hearing loss and otitis media in cleft palate children.

PURPOSE: Otitis media with effusion (OME), recurrent acute otitis media and conductive hearing loss (CHL) are significantly prevalent in children with cleft palate (CP) and cleft lip and palate (CLP). Rapid Maxillary Expansion (RME) appears to have a positive effect also on middle ear disorders in these patients. The study aims to offer a prospective evaluation of RME effects in a group of patients with CP/CLP in terms of OME, CHL. METHODS: A prospective observational study was conducted. Thirty-four CP, CLP and submucosa cleft patients who received orthodontic indication to RME treatment for OME or conductive hearing loss in a tertiary institutional Care Unit of San Paolo Hospital, Milan (IT), were included. Twenty-two patients matched for age and with analogous inclusion criteria except for indication to RME treatment were enrolled in the control group. Clinical otolaryngological evaluation, pure tone audiometry and tympanogram were performed at the beginning of treatment (T0), at the end of the expansion (T1) and at 6-month follow-up (T2). MAIN OUTCOME MEASURES: Air-bone gaps and tympanogram results at each time interval. RESULTS: In the main group, RME allowed a statistically significant improvement of air-bone gaps (according to frequency, p < 0.001-0.089 T0 vs. T1 and < 0.001-0.044 T0 vs. T2, Friedman's test) and tympanometry results (p = 0.002 T0 vs. T1 and p < 0.001 T0 vs. T2, Friedman's test). Improvements were stable during follow-up and were significantly better in the main group than in the control group. CONCLUSION: CHL and middle ear effusion improved significantly overtime during RME and after 6 months of follow-up.

Hearing Outcomes with Percutaneous and Transcutaneous BAHA® Technology in Conductive and Mixed Hearing Loss.

OBJECTIVES: To evaluate outcomes of BAHA Connect® and BAHA Attract® implantations, and to examine the prognostic utility of a preimplantation Softband®-attached processor trial. STUDY DESIGN: Retrospective case review. SETTING: Tertiary referral center. PATIENTS: Patients who underwent Connect® (19 ears) and Attract® (25 ears) implantation between 2007 and 2017. INTERVENTION: BAHA® implantation. MAIN OUTCOME MEASURES: Unaided air conduction (AC), bone conduction (BC), and speech reception thresholds (SRTs), as well as free field (FF) aided with Softband®-attached processor and with implant-attached processor thresholds. RESULTS: Serviceable implant-attached processor PTA0.5,1,2 kHz (≤35 dB HL) was achieved in 89 and 88% of the Connect® and the Attract® ears, respectively, while at 4 kHz this was achieved in 68 and 32% of the Connect® and the Attract® ears, respectively (p  =  0.032). Significantly more Connect® ears showed alignment between FF aided with implant-attached processors thresholds and BC thresholds. The alignment between the Softband®-attached processors thresholds and implant-attached processors thresholds was similar in the two groups. Both groups exhibited similar positive improvement in the quality of life questionnaires. CONCLUSIONS: Accessibility to sound with the implant-attached processor is well predicted by the pre-implantation Softband® trial, both in the BAHA Connect® and in the BAHA Attract® ears. Hearing rehabilitation targets at 0.5, 1, and 2 kHz are met by most Connect® and Attract® ears, while at 4 kHz the outcome with Attract® is poorer. This information should be presented to the patient during consultation prior to a decision as to the type of BAHA® device to be implanted.

Hearing Loss and Tinnitus.

A focused history, otoscopic and tuning fork examination and formal hearing testing are the diagnostic pillars for the workup of hearing loss and tinnitus. The causes of hearing loss and tinnitus are varied and range from relatively common age-related hearing loss to rare tumors of the brain and skull base. In this chapter, the authors explain the diagnostic workup of hearing loss and tinnitus, review the pathophysiology of the most common causes, and describe the treatments available.

One-Year Follow-Up in Children with Conductive Hearing Loss Using ADHEAR.

BACKGROUND: The ADHEAR™ system (MED-EL, Innsbruck, Austria) is a nonsurgical bone conduction device (BCD) to treat conductive hearing loss (CHL) and single-sided deafness. In contrast to the nonsurgical alternatives on headbands or spectacle frames, the audio processor of ADHEAR is placed retroauricularly on an adhesive adapter. The published evidence on the performance of this system is limited to studies with a trial period of 2-8 weeks. OBJECTIVE: This study assesses audiological and subjective outcomes over a period of 12 months, on patients with congenital aural atresia (CAA) using the ADHEAR hearing system. METHOD: Fifteen children (mean age: 9.4 ± 4 years; range: 5-16 years) diagnosed with CAA (7 uni/8 bilateral) were included in this prospective, observational, repeated-measures study. Each subject used ADHEAR for 1 year, and the performance was evaluated after 1, 6, and 12 months. Free-field audiometry and speech discrimination tests were performed, and hearing-, general health- and device-specific questionnaires were used. RESULTS: The unaided sound field threshold improved from an average PTA4 of 63.6 ± 3.4 dB HL to an aided average PTA4 of 29.3 ± 3.0 dB HL after 1 month of device use. The word recognition score (WRS) improved from an average of 27.9 ± 15.9% unaided to an aided average WRS of 91.3 ± 4.4% (p = 0.0003) after 1 month, 92.0 ± 4.1% (p = 0.0002) after 6 months, and 92.7 ± 5.3% (p < 0.0001) after 12 months using the ADHEAR system compared to the unaided condition for all 3 time points. The improvements in the speech in noise at 1, 6, and 12 months were as well consistent over time. The average improvement at the signal to noise ratio (SNR) of +5 dB was 58% and 53% at the SNR of +0 dB. No complications were reported, and all patients continued to use the ADHEAR after the study end. The questionnaire results revealed high user satisfaction and an average wearing time of 12 h per day. CONCLUSION: This 12-month trial of the nonsurgical adhesive BCD in CAA patients showed sufficient and reliable audiological and subjective outcomes, long wearing time, and high acceptance. The ADHEAR can be considered a suitable option to treat children with CAA for the given indication, without the drawbacks of nonsurgical devices that use pressure for retention of the audio processor or the costs and possible complications involved with a surgical alternative.

Salivary Gland Choristoma of the Middle Ear in a Child: A Case Report.

Salivary gland choristoma is an extremely rare middle ear pathology. We present the case of a 10-year-old girl with unilateral conductive hearing loss. Tympanotomy showed a nonspecific middle ear mass, absence of stapes, anomaly of incus, and displaced facial nerve. It was not possible to remove the mass completely. Histology confirmed salivary gland choristoma. The hearing in this case can be improved with a bone-anchored hearing aid.

Efficacy of cartilage conduction hearing aids in children.

OBJECTIVES: Cartilage conduction hearing aids (CC-HAs) are novel hearing aids that use the third hearing pathway of cartilage conduction. We assessed the efficacy of CC-HAs and the hearing effects and safety of additional tape compression over the transducer in children with hearing loss. METHODS: The patients (n = 42) underwent a one-month free trial of CC-HAs. Forty of them were patients with auditory canal atresia or stenosis. CC-HA-aided and unaided hearing thresholds (48 fitted ears) were determined using standard audiograms, after which participants could choose to purchase the device or not. We calculated the purchase rates and compared the patient characteristics between the purchase and non-purchase groups along with the purchase reason (or not). We applied additional tape compression over the CC-HA transducer and assessed the hearing effects and side effects. RESULTS: CC-HA led to hearing improvements at all frequencies. Overall, 72.92% of participants purchased a CC-HA after the trial. By applying additional tape compression over the CC-HA transducer, the stability and hearing gains were improved mainly at low frequencies, and no side effects such as dermatitis were observed. CONCLUSIONS: CC-HAs are efficacious in producing hearing improvements in children, especially in patients with atresia or canal stenosis who cannot use air conduction hearing aids. Furthermore, we found that the additional tape compression over the transducer was an easy and a safe method for improving the hearing effects and stability of the CC-HA.

Longitudinal economic analysis of Bonebridge 601 versus percutaneous bone-anchored hearing devices over a 5-year follow-up period.

OBJECTIVES: Percutaneous bone-anchored hearing devices (pBAHDs) are the most commonly used bone conduction implants (BCI). Concerns surround the long-term complications, notably skin-related, in patients with percutaneous abutments. The active transcutaneous BCI Bonebridge system can help avoid some of these pitfalls but is often considered a second-line option due to various factors including perceived increased overall costs. DESIGN: Longitudinal economic analysis of Bonebridge BCI 601 versus pBAHD over a 5-year follow-up period. SETTING: A specialist hearing implant centre. PARTICIPANTS: Adult patients (≥16 years) with conductive hearing loss, mixed hearing loss or single-sided deafness, who received a Bonebridge or pBAHD implant between 1/7/2013 and 1/12/2018 with a minimum 12-month follow-up. MAIN OUTCOME MEASURES: We compared the mean costs per implanted patient for both implants at 1, 3 and 5 years postoperative time points. Clinical effectiveness was evaluated using objective and patient-reported outcome measures. RESULTS: The mean total cost per patient of Bonebridge was significantly higher than pBAHD at 1-year post-implantation (£8512 standard deviation [SD] £715 vs £5590 SD £1394, P < .001); however, by 5-years post-implantation this difference was no longer statistically significant (£12 453 SD £2159 vs £12 575 SD £3854, P > .05). The overall cost convergence was mainly accounted for by the increased long-term complications, revision surgery rates and higher cost of the pBAHD external processor compared to Bonebridge. CONCLUSIONS: Long-term costs of Bonebridge to healthcare providers are comparable to pBAHDs, whilst offering lower complication rates, comparable audiological benefit and patient satisfaction. Bonebridge should be considered as a first-line BCI option in appropriate cases.

Hearing outcome measures for conductive and mixed hearing loss treatment in adults: a scoping review.

OBJECTIVE: Rehabilitation options for conductive and mixed hearing loss are continually expanding, but without standard outcome measures comparison between different treatments is difficult. To meaningfully inform clinicians and patients core outcome sets (COS), determined via a recognised methodology, are needed. Following our previous work that identified hearing, physical, economic and psychosocial as core areas of a future COS, the AURONET group reviewed hearing outcome measures used in existing literature and assigned them into different domains within the hearing core area. DESIGN: Scoping review. STUDY SAMPLE: Literature including hearing outcome measurements for the treatment of conductive and/or mixed hearing loss. RESULTS: The literature search identified 1434 studies, with 278 subsequently selected for inclusion. A total of 837 hearing outcome measures were reported and grouped into nine domains. The largest domain constituted pure-tone threshold measurements accounting for 65% of the total outcome measures extracted, followed by the domains of speech testing (20%) and questionnaires (9%). Studies of hearing implants more commonly included speech tests or hearing questionnaires compared with studies of middle ear surgery. CONCLUSIONS: A wide range of outcome measures are currently used, highlighting the importance of developing a COS to inform individual practice and reporting in trials/research.

Optimizing Management of Otophyma: A Case Series Highlighting the Role of Surgical and Retinoid Therapy.

Otophyma is a rare condition that can result in conductive hearing loss. Current otophyma literature does not examine validated treatment outcomes for patients. Utilizing a medical and surgical approach to maintain a patent canal can lead to significant objective improvements. The aim of this case series is to describe a combined successful approach in 3 cases from an academic, multidisciplinary center. The main outcomes analyzed were pre and post air-bone gap audiogram analysis and disimpaction frequency. The results showed that post-management, patient 1 had substantial improvement in hearing, recovering 49 dB in his right ear and 25 dB in his left ear, demonstrating near complete air-bone gap closure. Patient 2 showed a similar dermatologic and functional improvement, although objective audiometric assessment related to otophyma could not be performed due to coexisting chronic otitis media and cholesteatoma. Patient 3, in the 12 months prior to comanagement, had 8 bilateral disimpactions, and following comanagement had 2 disimpactions in 23 months. All 3 patients were pleased with the resultant functional and physical appearance following comanagement. By presenting this approach and objective measures of treatment, we hope to improve future clinical decision-making in a rare condition.

Effects of Occlusion and Conductive Hearing Loss on Bone-Conducted cVEMP.

OBJECTIVE: To evaluate the effects of conductive hearing loss and occlusion on bone-conducted cervical vestibular evoked myogenic potentials (cVEMPs). STUDY DESIGN: Prospective cohort study conducted in the year 2018. The right ear of each volunteer was evaluated under 3 conditions by using bone-conducted cVEMPs: normal (open external auditory canal), occluded (conductive hearing loss with occlusion effect), and closed (conductive hearing loss without the occlusion effect). SETTING: Single academic center. SUBJECTS AND METHODS: The study comprised 30 healthy volunteers aged 20 to 35 years (16 women, 14 men). All had normal hearing and no vestibular or auditory pathologies. The thresholds and amplitudes of cVEMP responses were recorded for the 3 conditions. The results of each condition for a particular participant were compared. RESULTS: As compared with the open condition, the conductive condition increased thresholds by 2.8 dB (P = .01), and the occluded condition decreased thresholds by 3.8 dB (P = .008). The amplitude in the occluded condition was larger than the normal condition and the conductive condition (mean difference: 20.64 [P = .009] and 31.76 [P < .001], respectively). CONCLUSION: The occlusion effect is present in cVEMP responses. The mechanism is not due to the conductive hearing loss induced. Clinical implications include potentially altering vestibular function with sealed hearing aids and in the surgically modified ears (ie, obliterated ears and open cavity mastoidectomy).

Longitudinal study of use of the pressure free, adhesive bone conducting hearing system in children at a tertiary centre.

OBJECTIVES: To assess the long-term compliance and usability of the non-implantable, adhesive bone conduction hearing aid system in children. Review of patient demographics, compliance and continued use. Identification of factors that impact on future patient selection. METHODS: Retrospective case series review of all children aged 5 and above fitted with the adhesive bone conduction hearing aid at a paediatric tertiary centre in the UK between 2015 and 2019. Data collected from medical and audiological records. Patient demographics, skin complications, patient feedback and changes in hearing aid provision were recorded. RESULTS: 82 children (40 female, 42 male) were provided with 89 adhesive hearing devices. To date 72 (87.8%) of the fitted patients, continue to use the device daily with minimal reported skin complications. Of the 10 patients that no longer use the adhesive aid, 5 no longer use any hearing device at all and the remaining 5 patients use an alternative hearing system. These include spectacle aids (n = 2) and bone anchored hearing implant (n = 3). CONCLUSION: Adhesive aid products are reported to provide comparable audiological results to the commercial softband hearing aids. They provide an excellent alternative in the treatment of conductive hearing loss without the costs and possible complications of a surgical intervention. A compliance rate of 87.8% of all patients fitted with the adhesive system demonstrates a high level of patient satisfaction. The device may also provide an appropriate stepping stone to implanted device once a child reaches the age in which an autonomous decision can be made. Limitations of the device have been the variability in the longevity of the adhesive adaptor and interference with headscarves, hats and glasses with a low frequency of transient minor skin reactions reported.

The effect of anatomical variables and use of the Lifts system on hearing outcomes after implantation of an active transcutaneous bone conduction device in bilateral congenital conductive hearing loss.

BACKGROUND: Malformations of the temporal bone present different challenges to the implantation of a transcutaneous active bone conduction device, such as Bonebridge (Med-el, Innsbruck, Austria). This study aims to describe the benefits of high-resolution computed tomography (HRCT) in preoperative assessment and to analyze whether characteristics of the mastoid process, intraoperative compression of the dura or sigmoid sinus, and the use of the Lifts system, lead to differences in audiological performance after implantation. METHODS: We examined 110 cases of congenital microtia. The structure of the temporal bone was examined using HRCT and a 3D simulation software program. The mean anteroposterior mastoid bone thickness from the external auditory canal to the sigmoid sinus was measured (a measurement referred to as "AP", hereafter). Sound field threshold (SFT), speech reception threshold (SRT) in noise, and word recognition score (WRS) in quiet, before and after implantation, were also measured. Independent variables were recorded in all patients: mastoid type (well pneumatized or poorly pneumatized), the presence of dural or sigmoid sinus compression, and the use of the Lifts system. RESULTS: We found that the mean AP in the non-compression group was 16.2 ± 2.3 mm and in the compression group, 13.1 ± 2.9 mm (p < 0.001). We analyzed the hearing improvement of patients grouped by mastoid development, dural or sigmoid sinus compression, and use of the Lifts system, and found that these factors did not interact and that they had no influence on the hearing outcomes (p > 0.05). CONCLUSIONS: The AP dimension in the non-compression group was significantly larger than that in the compression group. This finding combined with the ROC curve analysis revealed the AP dimension was a high-accuracy predictor of potential surgical complications involving the dura and sigmoid sinus compression. Further analysis revealed that there was no interaction between the chosen variables: mastoid type, dural or sigmoid sinus compression, and the use of the Lifts system, and that all of these factors had no significant impact on hearing performance. Bonebridge was shown to produce effective and stable bone conduction and to improve patients' hearing performance.

The Use of a Novel, Nonsurgical Bone Conduction Hearing Aid System for the Treatment of Conductive Hearing Loss.

OBJECTIVE: Conventional bone conduction hearing aid solutions often require a cumbersome retention system such as a headband or cap. This study aims to determine if a novel, nonsurgical bone conduction aid utilizing an adhesive attachment over the mastoid is equivalent to the conventional bone conduction hearing aid (BCHA) for the management of conductive hearing loss. STUDY DESIGN: Prospective, single-subject randomized, crossover trial. SETTING: Tertiary referral center. PATIENTS: Eleven adults and 1 child between 11 and 70 years of age with unilateral conductive hearing loss were enrolled. INTERVENTION: Patients had their baseline hearing assessed and were randomized to receive either the novel device or BCHA headband system. Hearing loss etiologies were varied and included cholesteatoma, otosclerosis, chronic otitis media, and previous head and neck surgery. Patients had their baseline hearing assessed and trialled both the novel device or the BCHA headband system. Patients were randomly assigned one device which was worn for 2 weeks followed by a 2-week trial with the alternate device. MAIN OUTCOME MEASURE: Pure-tone thresholds and speech discrimination in quiet and noise were tested and patients also completed the short form of the Speech Spatial and Quality of Hearing (SSQ) questionnaire. RESULTS: The mean unaided 4 frequency pure-tone average (PTA) air conduction threshold was 53.9 dB, bone conduction was 11.9 dB, and the mean air bone gap was 42 dB in the target ear. One patient with an adhesive skin reaction could not complete the protocol. Aided PTA and threshold testing between 250 Hz to 8000 Hz showed statistically equivalent results between both devices. The aided CNC word score, signal-to-noise ratio, and SSQ scores were also equivalent between both devices. CONCLUSION: The novel bone conduction aid demonstrates equivalent performance to the conventional BCHA headband solution. The novel device should be considered an alternative option where the cosmetic and comfort issues of a headband worn device are a concern.

A new adhesive bone conduction hearing system as a treatment option for transient hearing loss after middle ear surgery.

OBJECTIVE: The objective of this prospective, single-subject, repeated measures study was to evaluate the audiological benefit and patient satisfaction with an adhesive, pressure-free bone conduction hearing system (ADHEAR; MED-EL, Innsbruck, Austria) in patients who underwent middle ear surgery with transient hearing loss due to auditory canal tamponade. METHODS: Eleven adult subjects suffering from transient conductive hearing loss were enrolled in the study and followed up to 3 weeks after middle ear surgery. Bone and air conduction thresholds were measured pre and postoperatively to evaluate eligibility for enrollment. Postoperative unaided and aided sound-field thresholds, as well as speech tests in quiet and noise were compared to confirm hearing improvement with the hearing system. To determine patient satisfaction, the SSQ12 and a system-specific quality of life questionnaire was administered to all subjects. RESULTS: Speech perception for monosyllables in quiet improved by 46%, with statistical significance for the ADHEAR system compared to the unaided condition after one week. The functional hearing gain improved by 19 dB. Speech perception in noise with the device was - 6.7 dB SNR on average, with a statistically significant improvement of 2.7 dB SNR. The results of the questionnaire showed a high level of patient satisfaction and subjective hearing improvement. No serious skin reactions or other severe complications occurred. CONCLUSION: As long as the auditory canal is blocked due to tamponade, patients benefit from hearing rehabilitation. This adhesive hearing system is a safe and effective device to treat transient conductive hearing loss and may considerably improve treatment for patients even with short-term hearing loss.

Audiological benefit and subjective satisfaction of children with the ADHEAR audio processor and adhesive adapter.

OBJECTIVES: The main objective of this study was to evaluate the audiological benefit of the ADHEAR system in a group of children with a uni- or bilateral conductive hearing loss (CHL) during a short-term exposure of three weeks, and to compare it to a conventional bone conduction hearing aid (BCHA) on a softband. The secondary aim was to assess the quality of life improvement and patient satisfaction with the ADHEAR system. METHODS AND MATERIALS: The study was designed as a prospective study with repeated measures, where each subject served as his/her own control. Ten children (4-17 y/o) with a uni- or bilateral congenital or acquired CHL were included in this study. Pure tone audiometry and speech audiometry in quiet, both unaided and aided, were performed initially with the ADHEAR system and a BCHA on a softband, and after three weeks with the ADHEAR alone. Furthermore, patient satisfaction and quality of life were assessed using the SSQ12 and the ADHEAR questionnaire. RESULTS: The mean unaided free field hearing threshold of 50 dB HL (with 95%CI between 41.7 and 57.5 dB HL) expressed in 'Bureau International d'Audiophonologie' (BIAP), improved significantly by 22 dB (13.0-29.9) with the ADHEAR and by 23 dB (13.6-32.9) with the BCHA (p < 0.001). Furthermore, the mean unaided speech recognition threshold (SRT) in quiet improved significantly by 19 dB (10.3-28.1) with the ADHEAR and by 21 dB (12.6-29.4) with the BCHA (p < 0.001). For both audiological tests, there were no significant differences between the ADHEAR and the BCHA. After three weeks of use, the mean pure tone threshold of 28 dB HL (20.0-36.5) and the mean SRT of 47 dB SPL (41.9-51.5) with the ADHEAR system were comparable and not significantly different than the outcomes during the first visit. Speech understanding in noise and in multiple streams, sound localization and sound quality were rated significantly better with the ADHEAR, compared to the ratings without the ADHEAR system (p < 0.001). None of the children reported skin irritations or pain. CONCLUSIONS: The children included in our study had significantly improved hearing thresholds, speech perception in quiet and quality of life with the ADHEAR. The device can be an effective treatment method and a valuable alternative to other BCHA for children with a CHL, although the subjective experience of each child has to be taken into account. CLINICAL TRIAL REGISTRATION NUMBER: NCT03327194.

ACTIVE MIDDLE EAR VIBRANT SOUNDBRIDGE SOUND IMPLANT.

The Vibrant Soundbridge represents a new approach to hearing improvement in the form of active implantable middle ear hearing device. Unlike conventional acoustic hearing aids, which increase the volume of sound that goes to the eardrum, the Vibrant Soundbridge bypasses the ear canal and eardrum by directly vibrating the small bones in the middle ear. Because of its design, no portion of the device is placed in the ear canal itself. The Vibrant Soundbridge has been approved by the FDA as a safe and effective treatment option for adults with moderate to severe sensorineural, conductive or mixed hearing losses who desire an alternative to the acoustic hearing aids, for better hearing. The paper presents a review of the active middle ear implant Vibrant Soundbridge, which has been also implanted at the Department of Otorhinolaryngology and Head and Neck Surgery, Sestre milosrdnice University Hospital Center, which is the Referral Center for Cochlear Implantation and Surgery of Hearing Impairment and Deafness of the Ministry of Health, Republic of Croatia.