Evaluating the effectiveness and reliability of the Vibrant Soundbridge and Bonebridge auditory implants in clinical practice: Study design and methods for a multi-centre longitudinal observational study.

BACKGROUND: The Vibrant Soundbridge middle ear implant and the Bonebridge bone conducting hearing device are hearing implants that use radio frequency transmission to send information from the sound processor to the internal transducer. This reduces the risk of skin problems and infection but requires a more involved surgical procedure than competitor skin penetrating devices. It is not known whether more complex surgery will lead to additional complications. There is little information available on the reliability of these systems and adverse medical or surgical events. The primary research question is to determine the reliability and complication rate for the Vibrant Soundbridge and Bonebridge. The secondary research question explores changes in quality of life following implantation of the devices. The tertiary research question looks at effectiveness via changes in auditory performance. METHOD: The study was designed based on a combination of a literature search, two clinician focus groups and expert review.A multi-centre longitudinal observational study was designed. There are three study groups, two will have been implanted prior to the start of the study and one group, the prospective group, will be implanted after initiation of the study. Outcomes are surgical questionnaires, measures of quality of life, user satisfaction and speech perception tests in quiet and in noise. CONCLUSION: This is the first multi-centre study to look at these interventions and includes follow up over time to understand effectiveness, reliability, quality of life and complications.

Impact of Chronic Suppurative Otitis Media in Pediatric Cochlear Implant Recipients-Insight into the Challenges from a Tertiary Referral Center in UK.

OBJECTIVE: Analyze the presentation and evolution of chronic suppurative otitis media (CSOM) in children with cochlear implants (CI) and explore the merit of early intervention. STUDY DESIGN: Retrospective patient review. SETTING: Tertiary referral hospital and cochlear implant programme. PATIENTS: Children with a CI who developed CSOM. INTERVENTION: Tympanoplasty. MAIN OUTCOME MEASURES: Disease control, recurrence of cholesteatoma, cochlear implant preservation. RESULTS: Eight children fit our inclusion criteria with a mean follow up of 8 years. Onset of CSOM symptoms was observed on an average of 5 years after implantation (range, 2-13 yr) and led to surgical intervention in an average of 15.6 months following symptom onset. Cholesteatoma was found in four of the eight patients. Of these, one patient underwent a subtotal petrosectomy and explantation with reimplantation at the same stage but the reimplant failed to function and was explanted subsequently. One patient was initially managed by a canal wall up mastoidectomy and explantation but went on to require subtotal petrosectomy and labyrinthectomy for recurrent disease. One patient underwent a subtotal petrosectomy with explantation and is awaiting a reimplantation. The fourth patient had limited disease around the electrodes that was excised without compromising the implant. In the group of patients with CSOM without cholesteatoma, one underwent an explantation due to recurrent ear infections and a subsequent cartilage tympanoplasty for a retracted eardrum. The remaining three patients underwent successful excision of retraction pockets and repair of eardrums using cartilage with the implant in situ. A mean follow up of 2 years after the implant preservation surgeries shows good functioning of the CI. CONCLUSION: Early recognition of CSOM is paramount in patients with CI as delay in treatment can result in the infection spreading via the cochleostomy resulting in loss of the cochlea. Recurrent ear infections in an implanted ear should prompt early examination to exclude the presence of middle ear disease, which may require anesthesia in a young child.

Criteria versus guidelines: Are we doing the best for our paediatric patients?

The National Institute for Health and Care Excellence guidance for the provision of cochlear implants (NICE Technology Appraisal Guidance 166. Cochlear implants for children and adults with severe to profound deafness. 2009. National Health Service National Institute for Health and Clinical Excellence.) are used to develop candidacy criteria by public health funding bodies within the UK. Often the guidance is interpreted as strict 'criteria' whereby clinicians adhere to specific audiometric thresholds without accounting for the acceptable range of performance on individual tests or a child's functional development. In this paper four clinical paediatric case studies are described from two cochlear implant centres which serve to illustrate difficulties in applying NICE guidance as strict criteria. These are presented in the context of recommending more flexible interpretation based on the content of the current guidance along with considerations of circumstances where NICE guidance might be adapted to optimise use of cochlear implant technology within a national framework.

Cochlear implant assessment and candidacy for children with partial hearing.

Children who have partial hearing (PH) in the low frequencies and profound sensorineural hearing loss in the high frequencies can present a challenge to cochlear implant (CI) teams in terms of referral, assessment, and candidacy. Neither clinical criteria nor optimal timing for implantation has been explored in the literature. Data from both the Hearing Implant Centres of Birmingham Children's Hospital and St Thomas' Hospital indicate that it is clinically appropriate to implant children with PH; they perform better with CIs than with hearing aids, even if their hearing is not fully preserved. We have also found that children need early access to high frequency sound in order to reach their full potential.

Cochlear implantation in asymmetrical hearing loss for children: our experience.

Cochlear implantation in children with an asymmetrical hearing loss is now becoming more recognized as an appropriate and beneficial treatment option. In our programme, we have been implanting children with asymmetrical hearing loss since 2008. Asymmetrical hearing loss is defined as hearing loss when one ear meets criteria for cochlear implantation and the other ear has better hearing and receives benefit from a hearing aid. There is a wide range of asymmetrical hearing loss: single-sided deafness is the end of the spectrum. Amplification in asymmetrical hearing loss is usually difficult, it is often not possible to adequately aid the poorer ear; therefore patients often experience compromised hearing with adequate aiding of their better ear only. The impact of hearing with one ear on speech development, education, and employment is significant.

Bilateral sequential cochlear implantation in the congenitally deaf child: evidence to support the concept of a 'critical age' after which the second ear is less likely to provide an adequate level of speech perception on its own.

This study attempts to answer the question of whether there is a 'critical age' after which a second contralateral cochlear implant is less likely to provide enough speech perception to be of practical use. The study was not designed to predict factors that determine successful binaural implant use, but to see if there was evidence to help determine the latest age at which the second ear can usefully be implanted, should the first side fail and become unusable.Outcome data, in the form of speech perception test results, were collected from 11 cochlear implant programmes in the UK and one centre in Australia. Forty-seven congenitally bilaterally deaf subjects who received bilateral sequential implants were recruited to the study. The study also included four subjects with congenital unilateral profound deafness who had lost all hearing in their only hearing ear and received a cochlear implant in their unilaterally congenitally deaf ear. Of those 34 subjects for whom complete sets of data were available, the majority (72%) of those receiving their second (or unilateral) implant up to the age of 13 years scored 60 per cent or above in the Bamford Kowal Bench (BKB) sentence test, or equivalent. In contrast, of those nine receiving their second or unilateral implant at the age of 15 or above, none achieved adequate levels of speech perception on formal testing: two scored 29 per cent and 30 per cent, respectively, and the rest seven per cent or less.A discriminant function analysis performed on the data suggests that it is unlikely that a second contralateral implant received after the age of 16 to 18 years will, on its own, provide adequate levels of speech perception. As more children receive sequential bilateral cochlear implants and the pool of data enlarges the situation is likely to become clearer.The results provide support for the concept of a 'critical age' for implanting the second ear in successful congenitally deaf unilateral cochlear implant users. This would argue against 'preserving' the second ear beyond a certain age, in order to use newer models of cochlear implant or for the purpose of hair cell regeneration and similar procedures in the future. The results suggest a new and more absolute reason for bilateral implantation of congenitally deaf children at an early age.