Systemic methylprednisolone for hearing preservation during cochlear implant surgery: A double blinded placebo-controlled trial.

AIM: To assess whether a single, peri-operative, high dose of methylprednisolone can improve the preservation of residual acoustic hearing following cochlear implantation (CI). METHODS: This was a double blinded placebo-controlled trial, performed in a tertiary academic centre. The hypothesis was that methylprednisolone would improve the preservation of hearing, and lower electrode impedances. Adult patients (18-85 years) with hearing at 85 dB or better at 500 Hz in the ear to be implanted were randomly allocated to either treatment (methylprednisolone, 1g administered intravenously upon induction of anaesthesia) or control (normal saline infusion). As per standard clinical practice, all patients received a routine dose of dexamethasone (8 mg intravenously) on induction of anaesthesia. Implantation was undertaken with a slim and flexible lateral wall electrode via the round window. Surgical technique was routine, with adherence to soft surgical principles. The primary outcome was hearing preservation within 20 dB at 500 Hz, 12 months following cochlear implantation. Secondary outcomes included hearing preservation at 6 weeks and 3 months, monopolar electrode impedance, and Consonant-Vowel-Consonant (CVC) Phoneme scores at 3 and 12 months after surgery. RESULTS: Forty-five patients were enrolled into the control group and 48 patients received the steroid. The number of patients achieving hearing preservation at 12 months did not differ significantly between those receiving methylprednisolone treatment and the controls. There were no differences in hearing preservation at any frequency at either 6 weeks or 3 months after implantation. Neither CVC phoneme scores nor electrode impedances differed between the groups. CONCLUSIONS: This paper demonstrates that high-dose local steroid injection at surgery was not effective in preventing a loss of residual hearing, improving speech perception, or lowering electrode impedances. The findings were contrary to the experimental literature, and emerging clinical evidence that steroid elution from implant electrodes influences cochlear biology in humans. We found no evidence to support the widely-held practice of administering intravenous steroids in the perioperative period, in an attempt to preserve residual hearing.

Hearing Preservation Outcomes for 139 Cochlear Implant Recipients Using a Thin Straight Electrode Array.

OBJECTIVE: To assess the hearing preservation outcomes in a large group of adult cochlear implant recipients implanted with a thin straight electrode array using atraumatic surgical techniques. Factors affecting hearing preservation will be investigated. STUDY DESIGN: Prospective cohort study undertaken at the Royal Victorian Eye and Ear Hospital in Melbourne, Australia from December 2010 to May 2015. SETTING: Tertiary academic hospital. PATIENTS: One hundred thirty-nine adults undergoing cochlear implantation (CI). MAIN OUTCOME MEASURE: Primary outcome measure of interest was pre and postoperative pure-tone audiometry. RESULTS: Median low-frequency hearing change for the whole group of 139 recipients was -22.5 dB at the 3 months postop point. Eighty-six participants had functional preoperative low-frequency hearing (≤70 dB average at 250 and 500 Hz). Of these, 90.7% retained measureable hearing at 3 months postimplant. 39.5% of this original 86 participants retained functional hearing at 3 months postimplant. At 12 months postimplant, those who retained functional hearing at 3 months had no significant change in hearing. The group who lost functional hearing continued to have a significant deterioration in low-frequency hearing. Degree of hearing loss preimplant was identified as a predictor for the preservation of hearing postoperatively. CONCLUSION: Preservation of hearing is possible following atraumatic cochlear implant surgery with a thin straight electrode array. The amount of hearing preserved seems to be variable, and factors related to this variability are not yet known. The results of the present study suggest preoperative low-frequency hearing at or better than 45 dB may be related to preservation of functional hearing.

Barriers to early cochlear implantation.

OBJECTIVE: Identify variables associated with paediatric access to cochlear implants (CIs). DESIGN: Part 1. Trends over time for age at CI surgery (N = 802) and age at hearing aid (HA) fitting (n = 487) were examined with regard to periods before, during, and after newborn hearing screening (NHS). Part 2. Demographic factors were explored for 417 children implanted under 3 years of age. Part 3. Pre-implant steps for the first 20 children to receive CIs under 12 months were examined. RESULTS: Part 1. Age at HA fitting and CI surgery reduced over time, and were associated with NHS implementation. Part 2. For children implanted under 3 years, earlier age at HA fitting and higher family socio-economic status were associated with earlier CI. Progressive hearing loss was associated with later CIs. Children with a Connexin 26 diagnosis received CIs earlier than children with a premature / low birth weight history. Part 3. The longest pre-CI steps were Step 1: Birth to diagnosis/identification of hearing loss (mean 16.43 weeks), and Step 11: MRI scans to implant surgery (mean 15.05 weeks) for the first 20 infants with CIs under 12 months. CONCLUSION: NHS implementation was associated with reductions in age at device intervention in this cohort.

Long-term electrode impedance changes and failure prevalence in cochlear implants.

OBJECTIVE: This study assessed the prevalence of electrode failures and electrode impedance measures in Nucleus cochlear implants around initial activation (an average of 16 days after surgery) and after 8 to 12 years of device use. DESIGN: Retrospective data from the Melbourne Cochlear Implant Clinic was collated and analysed. STUDY SAMPLE: Included in this study were 232 adults, all of whom were implanted at the clinic between March 1998 and August 2005. RESULTS: Overall 0.5% of electrodes failed over the entire test period, with 5.6% of devices showing one or more electrode failure. The majority of these failures were recorded by initial activation. The numbers of electrode failures have decreased over time with array type, such that no failures were recorded with the currently available Contour Advance array. Array type was shown to affect electrode impedance at both time points, with the Contour and Contour Advance arrays having significantly higher absolute values than the Banded array. However, the Banded array had significantly higher area-normalized impedances at initial and final measures than the Contour and Contour Advance array. CONCLUSIONS: A relatively low incidence of electrode failures were recorded for the Nucleus devices of these recipients. Electrode impedance dropped for all array types after 8 to 12 years of device use.

Cochlear implants in forty-eight children with cochlear and/or vestibular abnormality.

CT and MRI scans for 48 children with cochlear and/or vestibular abnormality were classified in decreasing severity; common cavity, Mondini plus enlarged vestibular aqueduct, Mondini dysplasia alone and enlarged vestibular aqueduct alone. No significant relationship between degree of cochlea abnormality and surgical issues (cerebrospinal fluid gusher, depth of insertion, number of electrodes) or speech perception/language outcomes was found. A significant relationship was observed between cerebrospinal fluid gusher and partial electrode insertion, fewer active electrodes and poorer sentence understanding. Optimum language outcomes were associated with younger age at implant.

Speech detection and localization results and clinical outcomes for children receiving sequential bilateral cochlear implants before four years of age.

The aim of this study was to describe the adaptation to bilateral cochlear implant use and the perceptual benefits demonstrated by 10 children who were successful users of a first implant when a second was received before four years of age. Although one subject rejected the second implant at switch-on, the nine subjects who accepted the device adapted easily to bilateral implant use and developed useful listening skills with the second implant. Tests of localization (left versus right) and speech detection in noise were administered in the unilateral and bilateral conditions, usually after six months experience. All subjects demonstrated some bilateral benefit on speech detection testing (mostly due to a headshadow effect), and the majority localized left versus right. Results suggested that outcomes may be negatively impacted by increased age at the time of second implant switch-on. The majority of the subjects adapted well to bilateral implant use within six months and demonstrated some perceptual benefit and, according to subjective parent reports, improved daily functioning; however, device rejection must be discussed pre-operatively as a possibility.

Perceptual benefit and functional outcomes for children using sequential bilateral cochlear implants.

OBJECTIVE: To evaluate the additional perceptual benefit provided to children through the use of two cochlear implants in comparison to one after 6 to 13 mo experience with sequential bilateral implants. DESIGN: A second cochlear implant was received by 11 children. The principal selection criteria were being age 4 to 15 yr with a bilateral profound hearing loss and being a consistent user of a first implant with a commitment to use of a second implant. Horizontal localization was assessed by using pink noise bursts presented from a 180 degrees , eight-loudspeaker array. Speech perception was assessed by using a four-alternative forced-choice spondee test, with speech presented from in front and adaptive background noise presented from 90 degrees to the left or right. Both tests were completed in the first implant alone and bilateral conditions. A questionnaire measured the pre- to postoperative change in the parent's ratings of the child's performance in specific listening situations. Items were related to speech perception, spatial hearing, or other qualities of hearing. Regular parental reports of device use, attitude and performance were collected. Most subjects were assessed at 6 mo after surgery, with two assessed at 13 mo. RESULTS: The 11 subjects demonstrated a great range of outcomes. For one subject, only anecdotal data were collected. Speech perception testing indicated that when noise was presented ipsilateral to the first implant, 8 of 10 subjects showed a benefit in the bilateral condition. None of the nine subjects tested showed a benefit when noise was contralateral to the first implant. Generally, there was no benefit to localization in the bilateral condition. For eight subjects, postoperative performance ratings were generally higher than preoperative ratings, particularly in the spatial hearing section. Anecdotal reports indicated that most subjects had a negative attitude toward, and gained limited experience with, the second implant alone. The subjects developed a range of speech perception skills, from detection to conversation level. Regarding the use of bilateral implants, attitudes were more positive and device use was consistent for eight subjects, and six parents reported some evidence of improved performance in daily life. CONCLUSIONS: Children over age 4 yr may gain significant additional benefit from a second implant, including improved speech perception in some noise contexts and functional advantages in daily life. There is, however, no evidence from this study to suggest that binaural listening skills, including localization, will develop during the first 6 mo. Furthermore, some children who may be committed users of a first implant may not adapt to or benefit from a second implant during the first 6 mo of device use. Although the factors influencing benefit cannot be clearly identified, limited preoperative auditory experience with the second ear, a delay of years between implants, relatively advanced age, and lack of second-implant-alone experience do not preclude benefit. Continued evaluation of these and additional subjects will clarify the factors that do contribute to benefit. Such information will be vital in helping families of implanted children to make an informed decision regarding a second implant.

Otosclerosis: selection of ear for cochlear implantation.

OBJECTIVES: 1. To examine whether speech perception after implantation is correlated with the total duration of deafness, the duration of deafness in the implanted ear, or age at implantation. 2. To examine whether the rate of facial nerve stimulation postoperatively is correlated with the type of electrode used. STUDY DESIGN: Retrospective case note review. SETTING: Tertiary referral center. PATIENTS: Fifty-nine adults with profound postlingual sensorineural hearing loss due to otosclerosis. INTERVENTION: Cochlear implantation with the Nucleus device using either a straight (n = 35) or Contour (n = 29) electrode array. MAIN OUTCOME MEASURES: Speech perception scores for patients at 3, 6 and 12 months postimplantation were correlated against duration of deafness in the implanted ear, duration of total deafness, and age at implantation. Data on facial nerve stimulation rates postoperatively were collected. RESULTS: Implantation in the shortest deafened ear conferred an initial advantage for speech perception 3 months after surgery; however, this effect was lost by 6 months. There were no significant correlations between the duration of bilateral deafness and hearing outcomes. Age at implantation was negatively correlated with outcome at 3 months, but not at 6 and 12 months. Fourteen of 35 patients with straight electrodes and 0 of 24 patients with Contour electrodes experienced facial nerve stimulation during mapping sessions (p < 0.005, chi). CONCLUSION: Patients with otosclerosis are not disadvantaged in the long term by implantation in the longest deafened ear. Increasing age at implantation did not predict poorer outcomes. A perimodiolar design of electrode should be used in otosclerotic patients when possible to reduce the risk of facial nerve stimulation.

Cochlear implant and vestibular function.

OBJECTIVES: To document incidences of vestibular dysfunction after cochlear implantation and investigate why it occurs. This work was also motivated by a desire to provide the basis for better preoperative counseling and postoperative vestibular therapy to cochlear implant patients. SETTING: Melbourne Cochlear Implant Clinic at a tertiary referral hospital. STUDY DESIGN: Prospective observational study. PATIENTS: One hundred forty-six adult implant recipients, mean age, 60 years (range, 20-90 yr). MAIN OUTCOME MEASURES: Postoperative vestibular disturbance was defined as symptoms lasting for 1 week or longer after surgery. The differences in preoperative and postoperative vestibular function were measured from subjective assessments (Dizziness Handicap Inventory and Activity Balance Confidence questionnaires) and objective assessments (bithermal caloric tests). The position of the postoperative electrode was classified as "loose", "regular", or "tight" fitting. RESULTS: Thirty-two percent of patients reported vestibular disturbance and had poorer Dizziness Handicap Inventory, Activity Balance Confidence, and caloric results in the implanted ear after surgery. Patient age, cause, and preoperative caloric result did not predict postoperative vestibular symptoms. Recipients aged 70 years or older had significantly poorer caloric results on the implanted side after surgery that was not related to the intracochlear electrode position or surgical team. CONCLUSION: One-third of recipients can expect to experience a significant vestibular disturbance after surgery, regardless of age, cause, or preoperative caloric result. "Older" ears seem more prone to permanent injury after cochlear implantation.

Outcomes for cochlear implant users with significant residual hearing: implications for selection criteria in children.

OBJECTIVES: To develop an evidence-based technique for providing recommendations to candidates for cochlear implantation with significant residual hearing and to assess the efficacy of the approach. DESIGN: Modified selection criteria were derived from an analysis of the postoperative performance for a large group of adult cochlear implant users. In particular, the distributions of results for implant users with significant preoperative open-set speech perception were reviewed. This suggested that the candidates had a good chance (>75%) of overall improvement if they obtained open-set sentence scores in quiet of up to 70% in the best-aided condition and scores of up to 40% in the ear to undergo implantation. PATIENTS: A group of 45 adult implantation candidates who fit the modified criteria and who underwent preimplantation and postimplantation assessment to compare actual results with those predicted from the distributions. RESULTS: The speech perception results showed that 36 subjects (80%) had improved open-set sentence scores with the cochlear implant compared with their best-aided preoperative performance (mean improvement, 20.5%). Forty-four (98%) had improved open-set sentence scores for the ear undergoing implantation (mean improvement, 65.3%). CONCLUSIONS: The general concept of using the distribution of speech perception results to make evidence-based recommendations for candidates for cochlear implants is supported by this study. The approach can be used across different subpopulations, including older children with significant residual auditory skills, and for different outcome measures. It is important that the data used to provide recommendations and modify selection criteria are from an unselected sample of implant users of adequate size. This study highlights the continuing need to evaluate speech perception performance carefully before and after cochlear implantation.

Cochlear implants for children with significant residual hearing.

BACKGROUND: Previous research suggests that children with pure-tone averages of greater than 90 dB hearing level and/or open-set sentence perception of less than 30% may derive significant benefit from cochlear implantation. OBJECTIVE: To evaluate postoperative speech perception benefit and bilateral-bimodal benefit for 16 children whose preimplant speech perception scores exceeded conservative candidacy guidelines. STUDY DESIGN: Preimplant and postimplant repeated-measure design. METHODS: Sixteen child subjects who obtained 30% or greater on preimplant open-set sentence material, presented live voice audition alone, were selected for this study. Preimplant pure-tone averages ranged from 73 to 110 dB in the better aided ear. Preimplant and postimplant open-set word and sentence testing was completed in quiet and with competing background noise for separate ear and binaural conditions. RESULTS: Fourteen of 16 subjects had improved speech perception scores across all test materials after implantation. Group means were significantly higher for all test materials. Results in the bimodal-bilateral condition were significantly higher than implant alone for open-set word tests (scored for phonemes) and open-set sentences in quiet. CONCLUSION: The results of this study suggest that, with appropriate counseling and management, some children with significant residual hearing benefit from cochlear implantation, in particular improved speech understanding due to bimodal-bilateral hearing.

Speech perception outcomes in older children who use multichannel cochlear implants: older is not always poorer.

Speech perception outcomes for early-deafened children who undergo implantation as teenagers or young adults are generally reported to be poorer than results for young children. It is important to provide appropriate expectations when counseling adolescents and their families to help them make an informed choice regarding cochlear implant surgery. The considerable variation of results in this group makes this process more difficult. This study considered a number of factors in a group of 25 children who underwent implantation in Melbourne between the ages of 8 and 18 years. Each subject completed open-set speech perception testing with Bamford-Kowal-Bench sentences before and after implantation and preoperative language testing with the Peabody Picture Vocabulary Test. Data were collected regarding the type of hearing loss, age at implantation, age at hearing aid fitting, audiometric details, and preoperative and postoperative communication mode. Results were submitted to a stepwise multiple linear regression analysis with postoperative open-set sentence scores as the dependent variables. The analysis suggested that 3 factors have a significant predictive value for speech perception after implantation: preoperative open-set sentence score, duration of profound hearing loss, and equivalent language age. These 3 factors accounted for 66% of the variance in this group. The results of this study suggest that children who have useful speech perception before implantation, and higher age-equivalent scores on language measures, would be expected to do well with a cochlear implant. Consistent with other studies, a shorter duration of profound hearing loss is also advantageous. The mean sentence score for this group, 47%, was not significantly different from the mean result across all children in the Melbourne program.

Speech perception in children using cochlear implants: prediction of long-term outcomes.

A group of 102 children using the Nucleus multichannel cochlear implant were assessed for open-set speech perception abilities at six-monthly intervals following implant surgery. The group included a wide range of ages, types of hearing loss, ages at onset of hearing loss, experience with implant use and communication modes. Multivariate analysis indicated that a shorter duration of profound hearing loss, later onset of profound hearing loss, exclusively oral/aural communication and greater experience with the implant were associated with better open-set speech perception. Developmental delay was associated with poorer speech perception and the SPEAK signal coding scheme was shown to provide better speech perception performance than previous signal processors. Results indicated that postoperative speech perception outcomes could be predicted with an accuracy that is clinically useful.