Active transcutaneous bone conduction implant: audiological results in paediatric patients with bilateral microtia associated with external auditory canal atresia

Objective: To describe, in terms of functional gain and word recognition, the audiological results of patients under 18 years of age implanted with the active bone conduction implant, Bonebridge?. Design: Retrospective case studies conducted by reviewing the medical records of patients receiving implants between 2014 and 2016 in the public health sector in Chile. Study sample: All patients implanted with the Bonebridge were included (N?=?15). Individuals who had bilateral conductive hearing loss, secondary to external ear malformations, were considered as candidates. Results: The average hearing threshold one month after switch on was 25.2?dB (95%CI 23.5–26.9). Hearing thresholds between 0.5 and 4?kHz were better when compared with bone conduction hearing aids. Best performance was observed at 4?kHz, where improvements to hearing were observed throughout the adaptation process. There was evidence of a significant increase in the recognition of monosyllables. Conclusions: The Bonebridge implant showed improvements to hearing thresholds and word recognition in paediatric patients with congenital conductive hearing loss.     

Stability,survival, and tolerability of a 4.5-mm-wide bone-anchored hearing implant: 6-month data from a randomized controlled clinical trial

The objective of this study was to compare the stability, survival, and tolerability of 2 percutaneous osseointegrated titanium implants for bone conduction hearing: a 4.5-mm diameter implant (test) and a 3.75-mm diameter implant (control). Fifty-seven adult patients were included in this randomized controlled clinical trial. Sixty implants were allocated in a 2:1 (test–control) ratio. Follow-up visits were scheduled at 7, 14, 21, and 28 days; 6 and 12 weeks; and 6 months. At every visit, implant stability quotient (ISQ) values were recorded by means of resonance frequency analysis (RFA) and skin reactions were evaluated according to the Holgers classification. Implants were loaded with the bone conduction device at 3 weeks. Hearing-related quality of life was evaluated using the Abbreviated Profile of Hearing Aid Benefit (APHAB), the Glasgow Benefit Inventory (GBI), and the Glasgow Health Status Inventory (GHSI). ISQ values were statistically significantly higher for the test implant compared to the control implant. No implants were lost and soft tissue reactions were comparable for both implants. Positive results were reported in the hearing-related quality of life questionnaires. These 6-month results indicate that both implants and their corresponding hearing devices are safe options for hearing rehabilitation in patients with the appropriate indications. Loading at 3 weeks did not affect the stability of either implant.     

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.     

Retrosigmoid implantation of an active bone conduction stimulator in a patient with chronic otitis media

Percutaneous bone conduction implants are widely used in patients with conductive and mixed hearing loss with no benefit from conventional air conduction hearing aids. These devices have several complications including skin reaction, wound infection, growth of skin over the abutment, and implant extrusion. We describe a case of a transcutaneous bone conduction implantation (Bonebridge, Med-el) in a patient with conductive hearing loss due to chronic otitis media. Surgical planification was performed with the software 3D slicer 4.1. According to this program, the implant transductor was positioned in the retrosigmoid area. Aided thresholds demonstrate a significant benefit, with an improvement from 68 dB to 25 dB. Speech discrimination scores improved 35 dB. The patient is very happy and uses her device daily. The Bonebridge implant is a promising transcutaneous bone conduction implant for patients with conductive hearing loss. Retrosigmoid implantation may be useful in cases with mastoid pathology or previous surgery.     

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.     

A retrospective study on post-operative hearing of middle ear cholesteatoma patients with labyrinthine fistula

Conclusions: There is no significant change in bone conduction threshold after operation, so the tympanoplasty can be done to maintain hearing when conditions allow. Objective: To study the impact of surgical treatment on hearing of cholesteatoma patients with labyrinthine fistula. Methods: The clinical data of 35 patients (35 ears) with labyrinthine fistula, which were caused by cholesteatoma, were analyzed retrospectively. The hearing of 21 patients was followed up. Results: Three months to 5 years follow-up of 21 patients were accomplished by pure tone audiometry and other details. There was no recurrent cholesteatoma in the patients. Compared with pre-operative average bone conduction at 0.5, 1, 2, 4, and 8 kHz, 12 cases had a difference less than 5 dB, three patients’ hearing improved (more than 10 dB), and five cases declined (more than 10 dB). One patient received cochlear implantation 3 months after the surgery. The average bone and air conduction thresholds at 0.5, 1, 2, 4, and 8 kHz had no obvious change (p?>?0.05) in 11 patients managed by a canal wall down mastoidectomy with tympanoplasty.     

Teilimplantierbare transkutane Knochenleitungshörgeräte

Background

Patients with air-bone gaps or combined hearing loss that cannot be corrected by tympanoplasty can be treated with bone conduction hearing aids. The disadvantages of conventional and percutaneous systems are, on one hand, the obvious external fixation components and on the other hand, the biological and psychosocial problems of open implants. This project was therefore set up to develop a semi-implantable, magnetically anchored transcutaneous bone conduction device, introduce it into clinical application and follow-up the results.

Patients and methods

The principle of this bone conduction device is the magnetic coupling of an external vibrator via implanted double magnets. After extensive laboratory tests, this method was introduced into the clinic in 2006. Following the initial pilot study, 184 implantations in 143 patients have been performed in Recklinghausen since 2008. Long-term evaluation of 20 congenital atresia patients treated with these devices was possible.

Results

Worldwide, more than 3000 of these devices have been implanted. The operative implantation technique is relatively simple. With the new “upside down technique”, bone removal is no longer necessary. The 2.6-mm thin implants are hardly noticeable. The hearing improvement is similar to that of other bone conduction hearing aids.

Conclusion

This semi-implantable transcutaneous bone conduction hearing device is another option for patients with air-bone gaps, combined hearing loss or single-sided deafness.     

Our auditory results using the Vibrant Soundbridge on the long process of the incus: 20 years of data

Objective

After 20 years of experience with different types of middle ear implants, we analyzed our database about the Vibrant Soundbridge (VSB) to know the rate of complications, the effect on the residual hearing and the audiometric gain in our center.

Magnetic resonance imaging and bone anchored hearing implants: Pediatric considerations

Objective

Recent developments in bone conduction hearing systems have seen the introduction of transcutaneous devices comprising of magnetic components. Our aim was to identify the number of children implanted with a traditional, non-magnetic percutaneous bone anchored hearing implant (BAHI) who would not have been eligible for a transcutaneous implant based on magnetic resonance imaging (MRI) need.

Methods

A retrospective case review of 206 children who had a percutaneous BAHI at the Birmingham Children's Hospital (January 2009–October 2012) for auditory rehabilitation.

Results

Twenty-eight percent (56/206) of children required at least one MRI scan after receiving a BAHI and 10 percent of patients (20/206) required two or more MRI scans. The main indication for MRI scanning was for neurological co-morbidities; a MRI brain was the most common scan performed.

Conclusion

Although transcutaneous hearing devices/middle ear implants have their clear benefits, it may be argued that these relatively more invasive surgical procedures may not be the best option for the child who will require MRI scanning at some point in the future. Clinicians should be mindful of any need for MRI scanning when considering implant choices in the pediatric population.     

Clinical effect of an active transcutaneous bone-conduction implant on tinnitus in patients with ipsilateral sensorineural hearing loss

ObjectivesThis study investigated the effect of an active transcutaneous bone conduction implant (BoneBridge^?) in the management of tinnitus in patients with unilateral sensorineural hearing loss.MethodsFrom October 2016 to July 2018, 15 patients with unilateral tinnitus accompanied by ipsilateral sensorineural hearing loss received BoneBridge^? implants. Pure-tone average, tinnitus handicap inventory (THI), and a visual analogue scale (VAS) for awareness, loudness, and annoyance were measured before and 6 months after surgery. We defined improvement as a reduction of more than 20% between preoperative and postoperative VAS and THI scores, and changes in the THI of over 7 points were also assessed.ResultsMean THI scores before surgery (72.8 ± 16.1) had significantly improved by 6 months postoperatively (50.9 ± 18.9) (p = 0.003). VAS scores for loudness and annoyance also statistically significantly improved (p = 0.011 and 0.002). The amount of functional hearing gain correlated with changes in VAS scores for annoyance. This correlation was stronger with the improvement of high frequency hearing.ConclusionBoneBridge^? is beneficial in patients with tinnitus accompanied by sensorineural hearing loss. This finding can help select patients who will benefit most from bone conduction implants.     

A longitudinal study of the bilateral benefit in children with bilateral cochlear implants

Objective: To study the development of the bilateral benefit in children using bilateral cochlear implants by measurements of speech recognition and sound localization. Design: Bilateral and unilateral speech recognition in quiet, in multi-source noise, and horizontal sound localization was measured at three occasions during a two-year period, without controlling for age or implant experience. Longitudinal and cross-sectional analyses were performed. Results were compared to cross-sectional data from children with normal hearing. Study sample: Seventy-eight children aged 5.1–11.9 years, with a mean bilateral cochlear implant experience of 3.3 years and a mean age of 7.8 years, at inclusion in the study. Thirty children with normal hearing aged 4.8–9.0 years provided normative data. Results: For children with cochlear implants, bilateral and unilateral speech recognition in quiet was comparable whereas a bilateral benefit for speech recognition in noise and sound localization was found at all three test occasions. Absolute performance was lower than in children with normal hearing. Early bilateral implantation facilitated sound localization. Conclusions: A bilateral benefit for speech recognition in noise and sound localization continues to exist over time for children with bilateral cochlear implants, but no relative improvement is found after three years of bilateral cochlear implant experience.     

Self-reported benefit,sound perception,and quality-of-life in patients with auditory brainstem implants (ABIs)

Conclusion: The majority of the patients used their auditory brainstem implants (ABIs) all the time, reporting that he/she would make the decision to receive an implant again if the decision were reconsidered. The findings support that the ABI is a valuable treatment in patients with type 2 neurofibromatosis (NF2) and in children with congenital inner ear and nerve anomalies or cochlear ossification. Objective: To evaluate the patients who underwent ABI implantation in Uppsala during 1993–2013. This study analyzed patients’ implant use, perception of environmental sounds, perceived benefit from the implant, and quality-of-life (QoL). Method: The NF2-patients (n?=?20) comprised the majority of the patients, and there were a few non-NF2 pediatric patients (n?=?4). The exclusion criteria included deceased patients (n?=?4) and patients with no hearing sensations from the implant, or those with an inactivated ABI (n?=?2). The data were collected from a questionnaire survey. Results: Eleven adult patients and two pediatric patients answered the questionnaires. Eight of the adult patients used their implants ‘always’. The two children always used their implants. Hearing problems had the largest negative effect on the QoL. The non-users and the users scored equally on the NFTI-QoL.     

Outcome prediction for Bonebridge candidates based on audiological indication criteria

ObjectiveTo re-evaluate current indication criteria and to estimate the audiological outcomes of patients with Bonebridge bone conduction implants based on preoperative bone conduction thresholds.MethodsWe assessed the outcome of 28 subjects with either conductive or mixed hearing loss (CMHL) or single-sided deafness (SSD) who were undergoing a Bonebridge implantation. We used linear regression to evaluate the influence of preoperative bone conduction thresholds of the better/poorer ear, indication group, and language (German- and French-speaking patients) on aided sound field thresholds. In addition, aided word recognition scores at 65 dB sound pressure level were fit with a logistic model that included preoperative bone conduction thresholds of the better/poorer ear, indication group, and language as effects.ResultsWe found that both aided sound field thresholds and word recognition were correlated with the preoperative bone conduction thresholds of the better hearing ear. No correlation between audiological outcomes and the preoperative bone conduction thresholds of the poorer ear, language, or indication group was found.ConclusionBone conduction thresholds of the better hearing ear should be used to estimate the outcome of patients undergoing Bonebridge implantation. We suggest the indication criteria for Bonebridge candidates considering maximal bone conduction thresholds of the better ear at 38 dB HL to achieve an aided sound field threshold of at least 30 dB hearing level and an aided word recognition score of at least 75% for monosyllabic words.     

Soft tissue reactions around percutaneous implants: a clinical study of soft tissue conditions around skin-penetrating titanium implants for bone-anchored hearing aids

Some patients with hearing impairment cannot use conventional hearing aids. One solution for these patients is the use of bone conduction hearing aids; however, this kind of equipment is associated with several problems related to the necessity for a good contact between the transducer and the temporal bone. Direct bone contact would be an ideal solution provided that safe and reaction-free skin penetration and a safe and permanent bone anchorage could be achieved. Br?nemark et al have developed a procedure to furnish edentulous patients with fixed bridges using titanium implants. This report is focused on the clinical status of the soft tissue adjacent to the 67 skin-penetrating devices in 60 patients. The patients have been followed between 3 and 96 months on 313 occasions, which represents a total observation time of 1515 months of clinical performance. Only one implant was extracted due to adverse skin reaction, giving a failure rate of 0.07% per month. This is comparable with the failure rate of cardiac pacemakers 0.02-0.04% per month).     

Very far-advanced otosclerosis: stapedotomy or cochlear implantation

CONCLUSION: Every patient with severe or profound hearing loss must have a temporal bone high-resolution computed tomography (CT) scan. Stapedotomy is a simple, safe and low-cost procedure compared with cochlear implantation and can provide very good results. This can justify our decision to propose stapedotomy at the initial treatment in patients with very far-advanced otosclerosis. In cases of hearing failure after stapes surgery, cochlear implantation is an option. OBJECTIVE: This study aimed to find the best first intention treatment of very far-advanced otosclerosis. MATERIALS AND METHODS: This was a retrospective study and included 14 patients with non-measurable preoperative bone and air conduction thresholds and otosclerosis on temporal bone high-resolution CT scan. Stapes surgery followed by a well fitted hearing aid was the initial treatment in 11 patients and cochlear implantation in 7 patients, including 4 patients who had poor results after stapedotomy. Objective and subjective audiometric results were studied and compared between stapedotomy and cochlear implantation groups. RESULTS: Objective and subjective results were statistically better in the cochlear implant group than in the stapedotomy group. However, four patients in the stapedotomy group had comparable results to the patients with cochlear implants.     

Evaluation of the Digisonic® SP cochlear implant: patient outcomes and fixation system with titanium screws

Cochlear implants have revolutionized the way patients affected by severe hearing loss experience the world. Neurelec developed a fixation system with two titanium screws that requires no skull bone drilling.ObjectiveTo describe the outcomes and procedure-related details of a series of patients implanted with the Digisonic® SP cochlear implant.MethodThis retrospective study analyzed patients submitted to cochlear implant placement within a period of 18 months. All patients had postlingual hearing impairment. Data was collected from patient charts and standard questionnaires answered by the surgeons in charge of carrying out the procedures.ResultsThe six patients offered the Digisonic® SP cochlear implants were operated by experienced surgeons. The procedures took 95 to 203 minutes (mean = 135') to be completed, which is less time than what has been described for other fixation approaches. No complications were recorded and hearing improvement was satisfactory.ConclusionThe Digisonic® SP cochlear implant developed by Neurelec offered good audiological results for adult patients, shorter surgery time, and no surgical or postoperative complications.     

The role of stability measurements of the Baha system in children

Objective

Percutaneous bone conduction hearing aids are an established treatment for selected children unable to use conventional hearing aids. Currently in children, loading the implant is delayed for 3–6 months following fixture placement, due to concerns regarding bone quality, bone thickness and subsequent implant stability. Traditionally, such concerns led to children undergoing 2-stage Baha^® surgery, with a second operation to attach the abutment after 3–6 months. Bone conduction implant stability can be objectively measured using resonance-frequency analysis (RFA) to generate Implant Stability Quotients (ISQs). We aimed to assess implant stability in children undergoing 1-stage surgery using RFA measurements and investigate the possible implications for earlier loading following surgery.

Methods

We report a case series of consecutive children undergoing Baha^® at our tertiary paediatric hospital. The interval to implant loading remained 3–6 months for the duration of this study. RFA measurements were taken peri-operatively, 1 week post-surgery, within 3 months of surgery and then subsequently at follow up appointments. RFA measurements were also measured at loading of the hearing processor and at follow up appointments after loading.

Results

Nine children received 10 Cochlear™ Baha^® BI300 implants (8 unilateral and 1 bilateral) with a mean age of 9 years 4 months (4 years 9 months to 13 years 5 months). The mean time to loading of the hearing processor was 3.3 months (3 to 5 months, n = 9) and mean follow up was 9 months (12 weeks to 23 months). Eight children had ISQs that were potentially sufficient to have loaded the implant earlier than 3 months. Implant stability was maintained after loading with the hearing processor.

Conclusion

This study supports the potential use of RFA measurements to either, guide implant loading following 1-stage surgery in children, or to enable a larger prospective study of early loading (4–6 weeks) in children.     

Comparison of primary musicality development between children with cochlear implants and children with normal hearing

Abstract

Background: It is beneficial for CI patients listen to music. However it is necessary to take steps to improve the musicality of CI patients.

Objectives: The aims of the study were to evaluate the primary musicality of children with cochlear implants versus those with normal hearing.

Material and methods: Children participating in this study were divided into two groups: the cochlear implant group (CI group) and the normal hearing group (NH group). The ‘Musical Ears Evaluation Form for Professionals’ was used to evaluate the subjects’ primary musicality.

Results: The scores for overall and the three subcategories of primary musicality in children with cochlear implants and in those with normal hearing also improved significantly over time (p?<?.05). The score for overall primary musicality was not significantly different between CI and NH groups in the same hearing age (p?>?.05). There were significant differences between the two groups in the same chronological age (p?<?.05).

Conclusions and significance: The primary musicality in children with cochlear implants was not significantly different from normal hearing ones at the same hearing age. The primary musicality in children with cochlear implants was significantly lower than that of children with normal hearing at the same chronological age.     

Cochlear Implantation in Auditory Neuropathy

Objective: Auditory neuropathy is a recently described clinical entity characterized by sensorineural hearing loss in which the auditory evoked potential (ABR) is absent but otoacoustic emissions are present. This suggests a central locus for the associated hearing loss. In this study the results observed in a child with auditory neuropathy who received a cochlear implant are presented and compared with those of a matched group of children who were recipients of implants. Methods: A single-subject, repeated-measures design, evaluating closed-set and open-set word recognition abilities was used to assess the subject and a control group of matched children with implants who had also experienced a progressive sensorineural hearing loss. Results: The subject demonstrated improvements in vowel recognition (82% correct) by 1 year after implantation, which were only slightly lower than the control group. Consonant recognition and open-set word recognition scores were significantly lower. Conclusion: Caution should be exercised when considering cochlear implantation in children with auditory neuropathy. As with conventional hearing aids, less than optimal results may be seen.