Comparison of an Implantable Middle Ear Microphone and Conventional External Microphone for Cochlear Implants: A Clinical Feasibility Study.

OBJECTIVES: All commercially available cochlear implant (CI) systems use an external microphone and sound processor; however, external equipment carries lifestyle limitations. Although totally implantable devices using subcutaneous microphones have been developed, these are compromised by problems with soft tissue sound attenuation, feedback, and intrusive body noise. This in vivo pilot study evaluates a middle ear microphone (MEM) that aims to overcome these issues and compares hearing performance with that of an external CI microphone. DESIGN: Six adult participants with an existing CI were implanted with a temporary MEM in the contralateral ear. Signals from the MEM were routed via a percutaneous plug and cable to the CI sound processor. Testing was performed in the CI microphone and MEM conditions using a range of audiometric assessments, which were repeated across four visits. RESULTS: Performance of the MEM did not differ significantly from that of the CI on the assessments of Auditory Speech Sounds Evaluation loudness scaling at either 250 or 1000 Hz, or in the accuracy of repeating keywords presented at 70 dB. However, the MEM had significantly poorer aided sound-field thresholds, particularly at higher frequencies (≥4000 Hz), and significantly poorer performance on Arthur Boothroyd words presented at 55 dB, compared with the CI. CONCLUSION: In this pilot study, the MEM showed comparable performance to that of an external CI microphone across some audiometric assessments. However, performance with the MEM was poorer than the CI in soft-level speech (55 dB) and at higher frequencies. As such, the benefits of MEM need to be considered against the compromises in hearing performance. However, with future development, MEM is a potentially promising technology.

Skin flap thickness and magnet strength in Cochlear implants.

Objectives: The new CI600 series cochlear implants (Nucleus® Profile™ Plus Series; CI) are more MRI (magnetic resonance imaging) compatible. The magnet's attraction force is lower, possibly posing a problem in patients needing a higher strength magnet due to increased skin thickness. This study aims to investigate the relationship between skin thickness and magnet strength in patients undergoing cochlear implantation. Methods: This cross-sectional study used data from 46 patients with cochlear implants. Data collected included age, body mass index, magnet strength used, pre-operative and post-operative imaging and skin thickness. Results: There was a weak, positive correlation between magnet strength and skin thickness, which was not statistically significant (r(46) = 0.149, p = 0.324). There was a weak, positive correlation between magnet strength and body mass index, which was not statistically significant (r(46) = 0.113, p = 0.456). There was a moderate, positive correlation between body mass index and skin thickness, which was statistically significant (r(46) = 0.362, p = 0.012). Discussion: The increased skin thickness in patients with higher body mass indexes, might mean that these patients will require a stronger magnet. Conclusion: There are concerns that the lower attraction force in the CI600 (Nucleus® Profile™ Plus Series) may pose a retention problem for these patients. This might mean that discussions about skin flap reduction surgery are needed.

Cochlear implants for pre-lingually profoundly deaf adults.

INTRODUCTION: Increasing numbers of pre-lingually profoundly deaf adults are seeking a cochlear implant (CI). Pre- and post-operative outcomes are presented on 20 of these patients. RESULTS: An Adult Pre-Lingually Profoundly Deaf Implant Profile (APDIP) weighted the pre-operative level of concern about potential CI benefit. Results indicated no group mean post-operative open-set improvement. However CUNY sentence testing (auditory plus lip-reading cues) revealed improved performance with a CI. Twelve out of 20 patients used their CIs for more than 10 hours per day, suggesting good usage. Moreover, hours of usage were positively associated with measured benefit on CUNY sentences in the lip-reading plus sound via CI condition. There was no apparent relationship between pre-operative level of concern and post-operative CI performance or hours of processor use. CONCLUSION: Results suggest implantation is beneficial and effective in this group.

Comparison of the benefits of cochlear implantation versus contra-lateral routing of signal hearing aids in adult patients with single-sided deafness: study protocol for a prospective within-subject longitudinal trial.

BACKGROUND: Individuals with a unilateral severe-to-profound hearing loss, or single-sided deafness, report difficulty with listening in many everyday situations despite having access to well-preserved acoustic hearing in one ear. The standard of care for single-sided deafness available on the UK National Health Service is a contra-lateral routing of signals hearing aid which transfers sounds from the impaired ear to the non-impaired ear. This hearing aid has been found to improve speech understanding in noise when the signal-to-noise ratio is more favourable at the impaired ear than the non-impaired ear. However, the indiscriminate routing of signals to a single ear can have detrimental effects when interfering sounds are located on the side of the impaired ear. Recent published evidence has suggested that cochlear implantation in individuals with a single-sided deafness can restore access to the binaural cues which underpin the ability to localise sounds and segregate speech from other interfering sounds. METHODS/DESIGN: The current trial was designed to assess the efficacy of cochlear implantation compared to a contra-lateral routing of signals hearing aid in restoring binaural hearing in adults with acquired single-sided deafness. Patients are assessed at baseline and after receiving a contra-lateral routing of signals hearing aid. A cochlear implant is then provided to those patients who do not receive sufficient benefit from the hearing aid. This within-subject longitudinal design reflects the expected care pathway should cochlear implantation be provided for single-sided deafness on the UK National Health Service. The primary endpoints are measures of binaural hearing at baseline, after provision of a contra-lateral routing of signals hearing aid, and after cochlear implantation. Binaural hearing is assessed in terms of the accuracy with which sounds are localised and speech is perceived in background noise. The trial is also designed to measure the impact of the interventions on hearing- and health-related quality of life. DISCUSSION: This multi-centre trial was designed to provide evidence for the efficacy of cochlear implantation compared to the contra-lateral routing of signals. A purpose-built sound presentation system and established measurement techniques will provide reliable and precise measures of binaural hearing. TRIAL REGISTRATION: Current Controlled Trials http://www.controlled-trials.com/ISRCTN33301739 (05/JUL/2013).

Evaluation of bilaterally implanted adult subjects with the nucleus 24 cochlear implant system.

OBJECTIVE: To evaluate the speech perception benefits of bilateral implantation for subjects who already have one implant. STUDY DESIGN: Repeated measures. PATIENTS: Thirty adult cochlear implant users who received their second implant from 1 to 7 years with a mean of 3 years after their first device. Ages ranged from 29 to 82 years with a mean of 57 years. SETTING: Tertiary referral centers across the United Kingdom. MAIN OUTCOME MEASURES: Monosyllabic consonant-nucleus-consonant words and City University of New York sentences in quiet with coincident speech and noise and with the noise spatially separated from the speech by +/-90 degrees . RESULTS: At 9 months, results showed the second ear in noise was 13.9 +/- 5.9% worse than the first ear (p < 0.001); a significant binaural advantage of 12.6 +/- 5.4% (p < 0.001) over the first ear alone for speech and noise from the front; a 21 +/- 6% (p < 0.001) binaural advantage over the first ear alone when noise was ipsilateral to the first ear; no binaural advantage when noise was contralateral to the first ear. CONCLUSIONS: There is a significant bilateral advantage of adding a second ear for this group. We were unable to predict when the second ear would be the better performing ear, and by implanting both ears, we guarantee implanting the better ear. Sequential implantation with long delays between ears has resulted in poor second ear performance for some subjects and has limited the degree of bilateral benefit that can be obtained by these users. The dual microphone does not provide equivalent benefit to bilateral implants.