Minimum intraoperative testing battery for cochlear implantation: the international practice trend.

PURPOSE: In cochlear implantation (CI) surgery, there are a wide variety of intraoperative tests available. However, no clear guide exists on which tests must be performed as the minimum intraoperative testing battery. Toward this end, we studied the usage patterns, recommendations, and attitudes of practitioners toward intraoperative testing. METHODS: This study is a multicentric international survey of tertiary referral CI centers. A survey was developed and administered to a group of CI practitioners (n = 34) including otologists, audiologists and biomedical engineers. Thirty six participants were invited to participate in this study based on a their scientific outputs to the literature on the intraoperative testing in CI field and based on their high load of CI surgeries. Thirty four, from 15 countries have accepted the invitation to participate. The participants were asked to indicate the usage trends, perceived value, influence on decision making and duration of each intraoperative test. They were also asked to indicate which tests they believe should be included in a minimum test battery for routine cases. RESULTS: Thirty-two (94%) experts provided responses. The most frequently recommended tests for a minimum battery were facial nerve monitoring, electrode impedance measurements, and measurements of electrically evoked compound action potentials (ECAPs). The perceived value and influence on surgical decision-making also varied, with high-resolution CT being rated the highest on both measures. CONCLUSION: Facial nerve monitoring, electrode impedance measurements, and ECAP measurements are currently the core tests of the intraoperative test battery for CI surgery.

International Consensus Statements on Intraoperative Testing for Cochlear Implantation Surgery.

OBJECTIVES: A wide variety of intraoperative tests are available in cochlear implantation. However, no consensus exists on which tests constitute the minimum necessary battery. We assembled an international panel of clinical experts to develop, refine, and vote upon a set of core consensus statements. DESIGN: A literature review was used to identify intraoperative tests currently used in the field and draft a set of provisional statements. For statement evaluation and refinement, we used a modified Delphi consensus panel structure. Multiple interactive rounds of voting, evaluation, and feedback were conducted to achieve convergence. RESULTS: Twenty-nine provisional statements were included in the original draft. In the first voting round, consensus was reached on 15 statements. Of the 14 statements that did not reach consensus, 12 were revised based on feedback provided by the expert practitioners, and 2 were eliminated. In the second voting round, 10 of the 12 revised statements reached a consensus. The two statements which did not achieve consensus were further revised and subjected to a third voting round. However, both statements failed to achieve consensus in the third round. In addition, during the final revision, one more statement was decided to be deleted due to overlap with another modified statement. CONCLUSIONS: A final core set of 24 consensus statements was generated, covering wide areas of intraoperative testing during CI surgery. These statements may provide utility as evidence-based guidelines to improve quality and achieve uniformity of surgical practice.

Holistic assessment of cochlear implant outcomes using the international classification of functioning disability and health model: data analysis of a longitudinal prospective multicenter study.

PURPOSE: To study outcome after cochlear implantation using the Cochlear Implant (CI) outcome assessment protocol based on the International Classification of Functioning, Disability and Health (ICF) model (CI-ICF). METHODS: Raw data of a prospective, longitudinal, multicenter study was analyzed. Seventy-two CI candidates were assessed preoperatively and six months postoperatively using the CI-ICF protocol. Following tools were used: (1) Work Rehabilitation Questionnaire (WORQ), (2) Abbreviated Profile of Hearing Aid Benefit (APHAB), (3) Audio Processor Satisfaction Questionnaire (APSQ), (4) Speech, Spatial, and Qualities of Hearing Scale (SSQ12), (5) Hearing Implant Sound Quality Index (HISQUI19), (6) Nijmegen CI Questionnaire (NCIQ) (7) pure tone audiometry, (8) speech audiometry, (9) sound localization. RESULTS: There was a significant improvement of speech discrimination in quiet (p = 0.015; p < 0.001) and in noise (p = 0.041; p < 0.001), sound detection (p < 0.001), tinnitus (p = 0.026), listening (p < 0.001), communicating with-receiving-spoken messages (p < 0.001), conversation (p < 0.001), family relationships (p < 0.001), community life (p = 0.019), NCIQ total score and all subdomain scores (p < 0.001). Subjective sound localization significantly improved (p < 0.001), while psychometric sound localization did not. There was no significant subjective deterioration of vestibular functioning and no substantial change in sound aversiveness. CI users reported a high level of implant satisfaction postoperatively. CONCLUSION: This study highlights the positive impact of cochlear implantation on auditory performance, communication, and subjective well-being. The CI-ICF protocol provides a holistic and comprehensive view of the evolution of CI outcomes.

The MED-EL SONATATI 100 cochlear implant: an evaluation of its safety in adults and children.

CONCLUSIONS: Data from 50 patients suggest that the SONATATI(100) cochlear implant (CI) is a safe and effective device. OBJECTIVE: MED-EL has developed and tested a CI with titanium housing (the SONATATI(100)), which has the same internal components as the PULSARCI(100). Implant surgery should be less traumatic, as with these CIs smaller incisions and less drilling are involved. The study aimed to assess surgical issues pertaining to the implantation of the device, patient compatibility with the titanium of the implant housing, and other patient-related issues. METHODS: Fifty patients were recruited into this multicenter study. In phase 1, 30 adults and in phase 2, 20 children received a SONATATI(100) cochlear implant. An intraoperative survey was completed by the surgeons for all patients. A postoperative survey was completed by the audiologists/fitting engineers at first fitting and 3 and 6 months after the first fitting to evaluate the safety and the efficacy of the device. RESULTS: The device was proven to be effective in that it was stable in the implant bed and that minimally invasive surgery could be carried out. The device was proven to be safe after medium-term use and no unexpected adverse events were reported.

Combined electric acoustic stimulation with the PULSARCI(100) implant system using the FLEX(EAS) electrode array.

CONCLUSION: This study demonstrates that electric acoustic stimulation (EAS(®)) using the FLEX(EAS) electrode is a successful treatment method for preservation and stability of low frequency hearing, and results in significant improvements in speech perception. OBJECTIVES: Low frequency hearing preservation and stability following EAS surgery with the MED-EL PULSARCI(100) implant using the FLEX(EAS) electrode and a combined processor in a multicentre setting, and the efficacy and benefits of EAS over time were evaluated. METHODS: Eighteen subjects with normal to moderate hearing loss in the low frequencies and severe to profound hearing loss in the high frequencies were implanted with the FLEX(EAS) electrode. Implantation was performed by different surgeons at three participating centres using either the cochleostomy or the round window approach. Preoperatively, hearing was measured; a battery of speech perception tests and the subjective benefit questionnaire were administered. These tests were subsequently repeated: first at EAS fitting, which was due 3 months after surgery, and then again 3, 6 and 12 months after EAS fitting. RESULTS: Hearing could be preserved in all subjects. Speech understanding showed significant improvement in all tests over time with the EAS condition outperforming the cochlear implant-only condition at all intervals. These considerable effects were also reflected in the subjective benefit outcome.

Electric acoustic stimulation of the auditory system: results of a multi-centre investigation.

CONCLUSION: A high rate of hearing preservation during cochlear implantation for electric acoustic stimulation (EAS) is possible, even when surgery is conducted by a number of different surgeons. OBJECTIVES: This study aimed to determine the degree of hearing preservation using surgery for EAS in a European multi-centre clinical investigation. It also aimed to demonstrate the effect of EAS in individuals with residual low frequency hearing, both on speech perception and on subjective quality of life measures. PATIENTS AND METHODS: Eighteen patients with profound high frequency hearing loss were recruited in five participating European centres. Subjects were assessed based on an audiologic test battery, as well as on a subjective hearing aid benefit questionnaire. Each subject underwent attempted hearing preservation cochlear implantation using the MED-EL C40 + device with a Medium electrode. Residual ipsilateral hearing and speech discrimination abilities were assessed at defined intervals up to 12 months after the combined electric-acoustic mode was introduced. RESULTS: Results showed that some degree of hearing preservation was possible in 15718 patients. All subjects showed statistically significant benefit on all three speech perception tests over time. These significant benefits were also reflected in the subjective benefit outcomes.

Partial deafness cochlear implantation in children.

OBJECTIVE: Partial deafness cochlear implantation and electric-acoustic stimulation have proven to be a useful method of treating adults with a ski-slope type hearing loss. Good hearing preservation and speech perception outcomes have been reported. This study aims to assess partial deafness cochlear implantation in children. METHOD: Nine children, ranging in age from 4.2 to 12 years, received a cochlear implant following the round window surgical technique for partial deafness cochlear implantation. Hearing preservation was assessed by pure-tone audiometry and speech perception outcomes were measured using monosyllable word tests in quiet and noise. Data are available for most children up to a period of 1 year. RESULTS: Hearing could be preserved partially in all cases, however, one child does not have sufficient preservation to make use of electric-acoustic stimulation. The eight children with sufficiently preserved hearing either use the natural low frequency hearing in combination with a cochlear implant to hear or use the DUET combined hearing system. Speech perception tests showed improvement in quiet and noise over time. CONCLUSION: Results suggest that partial deafness cochlear implantation is a viable treatment method in children. However, surgery should only be conducted by an experienced surgeon and parents need to be carefully counselled about the risks and benefits of partial deafness cochlear implantation.

Outcomes in adults implanted with the FLEXsoft electrode.

CONCLUSION: Achieving deep insertions, as well as good speech perception results, the FLEXsoft electrode array allows for some preservation in subjects with measurable low frequency hearing, even after a period of time. This opens the door for future research in electrode design, hearing preservation research and drug delivery systems. OBJECTIVES: The FLEXsoft electrode is designed to be atraumatic to the structures of the cochlea during deep insertion of a cochlear implant electrode. This paper reports on the surgical and functional outcomes in implantations with the FLEXsoft electrode array. PATIENTS AND METHODS: Twenty-three adult subjects received a FLEXsoft electrode array and were assessed on speech perception tests (monosyllables, sentences in quiet and in noise), a subjective questionnaire (Nijmegen Cochlear Implant Questionnaire) and a pure-tone audiogram. Results at 1, 3, 6 and 12 months post first fitting were compared to scores from the preoperative interval. RESULTS: Surgery was uneventful in all cases, the surgical handling was satisfactory and correct position of the electrode was achieved in all cases. Hearing could be preserved (as determined by the audiogram) in half of the subjects who had measurable audiograms preoperatively at the 1 month test interval, and in a quarter of subjects after 12 months of device use, despite deep insertion of the electrode. Speech perception scores showed significant improvement over time, as did quality of life scores, and were comparable to results with the standard electrode array as used in the COMBI 40+ and PULSARCI100.

Double posterior labyrinthotomy technique: results in three Med-El patients with common cavity.

HYPOTHESIS: This study reports on the use of the double posterior labyrinthotomy surgical technique and a custom-designed electrode to ensure better positioning of stimulating electrodes within the common cavity and thus demonstrate suitable outcomes in patients. BACKGROUND: Cochlear implantation has proven beneficial for numerous children with congenital malformations of the inner ear. Several studies show good auditory perception outcomes in children with common cavity. However, there have been risks involved with surgical techniques used in the actual implantation. These include possible aberrant facial nerve and the strong potential for a cerebrospinal fluid gusher. Improved surgical techniques and electrode design could allow for better electrode contact and avoid electrode placement in the internal auditory meatus. METHOD: The double posterior labyrinthotomy technique was carried out in three cases using a custom made MED-EL COMBI 40+ electrode. RESULTS: Surgery was carried out with no complications and is no more technically demanding than other standard surgical approaches. The speech processor program remains stable over time, and auditory perception results are similar to those obtained from children with no cochlear abnormalities. CONCLUSION: These results demonstrate the success of the double posterior labyrinthotomy approach with modified cochlear implant, and this could be recommended as the procedure of choice in children presenting to an implant team with a common cavity.

Preservation of residual hearing in children and post-lingually deafened adults after cochlear implantation: an initial study.

OBJECTIVE: To investigate whether the residual hearing of severely hearing-impaired children and adults could be preserved using the soft surgery approach. PATIENTS AND METHODS: This project employed a prospective study design. All testing and surgery took place in the Institute of Physiology and Pathology of Hearing, Warsaw, Poland. Twenty-six patients (7 children and 19 post-lingually deafened adults) with residual hearing were assessed. Subjects were assessed using conventional pure-tone audiometry at least 1 month prior to surgery. Cochlear implant surgery with a Med-El Combi 40/40+ standard electrode array was conducted, using the soft surgery approach. Pure-tone audiometry thresholds were re-assessed at least 1 month after surgery. The researchers assessed change in auditory thresholds using pure-tone audiometry to determine preservation of residual hearing. RESULTS: Sixteen of 26 patients (62%) retained their residual hearing within 5 dB HL of pre-operative scores. Only 5 of 26 patients (19%) lost all measurable residual hearing after cochlear implantation. This suggests that surgeons are often able to preserve residual hearing during cochlear implant surgery using the soft surgery technique. CONCLUSIONS: Preservation of residual hearing is an important consideration in cochlear implantation in the light of changing selection criteria for cochlear implant candidates, and as younger children are receiving implants. This is important, as we do not know yet the long-term effects of inner ear damage due to traumatic insertions of electrodes. This finding suggests a good prognosis for future possibilities of re-implantation.