Preservation Of Residual Hearing Research Articles

Advances in hearing preservation in cochlear implant surgery.

Advancements in cochlear implant surgical approaches and electrode designs have enabled preservation of residual acoustic hearing. Preservation of low-frequency hearing allows cochlear implant users to benefit from electroacoustic stimulation, which improves performance in complex listening situations, such as music appreciation and speech understanding in noise. Despite the relative high rates of success of hearing preservation, postoperative acoustic hearing outcomes remain unpredictable. Thin, flexible, lateral wall arrays are preferred for hearing preservation. Both shortened and thin, lateral wall arrays have shown success with hearing preservation and the optimal implant choice is an issue of ongoing investigation. Electrocochleography can monitor cochlear function during and after insertion of the electrode array. The pathophysiology of hearing loss acutely after cochlear implant may differ from that involved in delayed hearing loss following cochlear implant. Emerging innovations may reduce cochlear trauma and improve hearing preservation. Hearing preservation is possible using soft surgical techniques and electrode arrays designed to minimize cochlear trauma; however, a subset of patients suffer from partial to total loss of acoustic hearing months to years following surgery despite evidence of residual apical hair cell function. Early investigations in robotic-assisted insertion and dexamethasone-eluting implants show promise.

Initial Experience With a Recently Developed Lateral Wall Electrode.

To review our hearing preservation rates and speech recognition outcomes in patients undergoing cochlear implantation with a recently developed lateral wall electrode. Retrospective cohort study. Retrospective case series of all patients, both pediatric and adult, undergoing cochlear implantation with the Advanced Bionics Hifocus™ SlimJ electrode between December 2017 and January 2020. Main outcomes included hearing preservation rates using several definitions, speech recognition testing primarily through Arizona Biosciences (AzBio) and Consonant-Nucleus-Consonant (CNC) testing, intra- and postoperative complications. Sixty-one ears underwent implantation with the new electrode. Hearing preservation rates were 13.0% to 36.0% depending on the definition used. Speech recognition testing showed significant increases from pre- to postoperative condition (Implant-only AzBio: 24.1 to 48.3, P=.004, binaural AzBio: 46.1 to 65.9, P=.002, Implant-only CNC: 9.7 to 35.1, P < .001, binaural CNC: 29.8 to 59.40, P < .001) with last speech recognition testing occurring an average of 8.8 months postoperatively. The elderly population had the worst hearing preservation rates across all definitions. Five explantations were required due to two infections and three device failures. Hearing preservation rates varied significantly depending on the definition used, but users experienced a significant improvement in speech recognition testing after implantation. More work is needed in the community to standardize the definition of residual hearing and hearing preservation. 4 Laryngoscope, 131:2782-2788, 2021.

Zwitterionic Photografted Coatings of Cochlear Implant Biomaterials Reduce Friction and Insertion Forces.

Application of photografted zwitterionic coatings to cochlear implant (CI) biomaterials will reduce friction and insertion forces. Strategies to minimize intracochlear trauma during implantation of an electrode array are critical to optimize outcomes including preservation of residual hearing. To this end, advances in thin-film zwitterionic hydrogel coatings on relevant biomaterials may show promise, in addition to the potential of these materials for decreasing the intracochlear foreign body response. Using a recently designed one-step process, thin-film coatings derived from zwitterionic sulfobetaine methacrylate (SBMA) were photopolymerized and photografted to the surface of polydimethylsiloxane (PDMS, silastic) samples and also to CI arrays from two manufacturers. Fluorescein staining and scanning electron microscopy with energy-dispersive X-ray spectroscopy verified and characterized the coatings. Tribometry was used to measure the coefficient of friction between uncoated and coated PDMS and synthetic and biological tissues. Force transducer measurements were obtained during insertion of uncoated (n = 9) and coated (n = 9) CI electrode arrays into human cadaveric cochleae. SBMA thin-film coating of PDMS resulted in >90% reduction in frictional coefficients with steel, ceramic, and dermal tissue from guinea pigs (p < 0.0001). We employed a novel method for applying covalently bonded, durable, and uniform coating in geographically selective areas at the electrode array portion of the implant. Image analysis confirmed uniform coating of PDMS systems and the CI electrode arrays with SBMA polymer films. During insertion of electrode arrays into human cadaveric cochleae, SBMA coatings reduced maximum force by ∼40% during insertion (p < 0.001), as well as decreasing force variability and the overall work of insertion. Thin-film SBMA photografted coatings on PDMS and electrode arrays significantly reduce frictional coefficients and insertional forces in cadaveric cochleae. These encouraging findings support that thin-film zwitterionic coating of CI electrode arrays may potentially reduce insertional trauma and thereby promote improved hearing and other long-term outcomes.

Long-Term, Multicenter Results With the First Transcutaneous Bone Conduction Implant.

Investigation of long-term safety and performance of an active, transcutaneous bone conduction implant in adults and children up to 36 months post-implantation. Prospective, single-subject repeated-measures design. Otolaryngology departments of eight German and Austrian hospitals.∗†‡§||¶#∗∗†† Affiliations listed above that did not participate in the study.‡‡§§||||¶¶. Fifty seven German-speaking patients (49 adults and eight children) suffering from conductive or mixed hearing loss, with an upper bone conduction threshold limit of 45 dB HL at frequencies between 500 and 3000 Hz. Implantation of the Bonebridge transcutaneous bone conduction hearing implant (tBCI). Patients' audiometric pure tone averages (PTA4) (0.5, 1, 2, 4 kHz) thresholds (air conduction, bone conduction, and sound field) and speech perception (word recognition scores [WRS] and speech reception thresholds [SRT50%]) were tested preoperatively and up to 36 months postoperatively. Patients were also monitored for adverse events and administered quality-of-life questionnaires. Speech perception (WRS: pre-op: 17.60%, initial activation [IA]: 74.23%, 3M: 83.65%, 12M: 83.46%, 24M: 84.23%, 36M: 84.42%; SRT50%: pre-op: 65.56 dB SPL, IA: 47.67 dB SPL, 3M: 42.61 dB SPL, 12M: 41.11 dB SPL, 24M: 41.74 dB SPL, 36M: 42.43 dB SPL) and sound field thresholds (pre-op: 57.66 dB HL, IA: 33.82 dB HL, 3M: 29.86 dB HL, 12M: 28.40 dB HL, 24M: 28.22 dB HL, 36M: 28.52 dB HL) improved significantly at all aided postoperative visits. Air and bone conduction thresholds showed no significant changes, confirming preservation of patients' residual unaided hearing. All adverse events were resolved by the end of the study. Safety and performance of the tBCI was demonstrated in children and adults 36 months postoperatively.

Vestibular Preservation After Cochlear Implantation Using the Round Window Approach.

Background: The development of less traumatic surgical techniques, such as the round window approach (RWA), as well as the use of flexible electrodes and post-operative steroid administration have enabled the preservation of residual hearing after cochlear implantation (CI) surgery. However, consideration must still be given to the complications that can accompany CI. One such potential complication is the impairment of vestibular function with resulting vertigo symptoms. The aim of our current study was to examine the changes in vestibular function after implantation in patients who received CI using less traumatic surgery, particularly the RWA technique.Methods: Sixty-six patients who received CI in our center were examined by caloric testing, cervical vestibular evoked myogenic potential (cVEMP) and ocular VEMP (oVEMP) before or after implantation, or both, to obtain data on semicircular canal, saccular and utricular function, respectively. Less traumatic CI surgery was performed by the use of the RWA and insertion of flexible electrodes such as MED-EL FLEX soft, FLEX 28, and FLEX 24 (Innsbruck, Austria).Results: Caloric response and the asymmetry ratio of cVEMP and oVEMP were examined before and after implantation using less traumatic surgical techniques. Compared with before implantation, 93.9, 82.4, and 92.5% of the patients showed preserved vestibular function after implantation based on caloric testing, cVEMP and oVEMP results, respectively. We also examined the results for vestibular function by a comparison of the 66 patients using the RWA and flexible electrodes, and 17 patients who underwent cochleostomy and insertion of conventional or hard electrodes. We measured responses using caloric testing, cVEMP and oVEMP in patients after CI. There were no differences in the frequencies of abnormal caloric and oVEMP results in the implanted ears between the RWA and cochleostomy. On the other hand, the frequency of abnormal cVEMP responses in the implanted ears in the patients who received implantation by cochleostomy was significantly higher than that in the patients undergoing surgery using the RWA.Conclusion: Patients receiving CI using less traumatic surgical techniques such as RWA and flexible electrodes have reduced risk of damage to vestibular function.

Evaluation of hearing preservation in adults with a slim perimodiolar electrode

PurposeNumerous endeavors have been undertaken to preserve hearing in cochlear implant (CI) patients. Particularly, optimization of electrode array design aims at preservation of residual hearing (RH). This study examines whether a slim perimodiolar (PM) electrode array could bear the capability to preserve hearing.MethodsA total of 47 patients underwent cochlear implantation receiving the PM electrode. (i) Patients with pure tone audiogram (PTA) thresholds better than 85 dB and/or hearing loss for Freiburg speech test numbers less than 60 dB and more than 50% maximum monosyllabic understanding were assigned to the RH group (n = 17), while all others belonged to the noRH group (n = 30). (ii) Another group implanted with a slim straight, lateral wall (LW) electrode was recruited for comparison.ResultsWe compared 17 RH–30 noRH patients all receiving the PM electrode. RH in PM recipients decreased faster than in LW recipients. No significant differences were observed between both (RH v/s noRH) groups in NRT thresholds, Freiburg speech test and A§E® phonemes. Analogous satisfaction levels were indicated through the questionnaires in terms of sound quality, hearing in silence, noise and directional hearing in both groups.ConclusionsThe results suggest that hearing preservation is influenced not only by electrode shape but various factors. This study opens an avenue for further investigations to elucidate and enumerate the causes for progressive hearing loss.

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

AimTo assess whether a single, peri-operative, high dose of methylprednisolone can improve the preservation of residual acoustic hearing following cochlear implantation (CI). MethodsThis 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. ResultsForty-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. ConclusionsThis 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.

Residual hearing preservation for cochlear implantation surgery.

Cochlear implantation (CI) has developed for more than four decades. Initially, CI was used for profound bilateral hearing impairment. However, the indications for CI have expanded in recent years to include children with symptomatic partial deafness. Therefore, CI strategies to preserve residual hearing are important for both patients and otologists. The loss of residual low-frequency hearing is thought to be the result of many factors. All surgical methods have the same goal: protect the delicate intracochlear structures and preserve residual low-frequency hearing to improve speech perception abilities. Fully opening the round window membrane, a straight electrode array, slower insertion speed, and the use of corticosteroids result in a higher rate of hearing preservation. Several factors, like the way of surgical approaches, length of arrays and timing of activation, may not affect the residual hearing preservation. Therefore, the classic atraumatic technique, including the very slow and delicate insertion and administration of intraoperative corticosteroids, can improve hearing outcomes.

Residual Hair Cell Responses in Electric-Acoustic Stimulation Cochlear Implant Users with Complete Loss of Acoustic Hearing After Implantation.

Changes in cochlear implant (CI) design and surgical techniques have enabled the preservation of residual acoustic hearing in the implanted ear. While most Nucleus Hybrid L24 CI users retain significant acoustic hearing years after surgery, 6-17 % experience a complete loss of acoustic hearing (Roland et al. Laryngoscope. 126(1):175-81. (2016), Laryngoscope. 128(8):1939-1945 (2018); Scheperle et al. Hear Res. 350:45-57 (2017)). Electrocochleography (ECoG) enables non-invasive monitoring of peripheral auditory function and may provide insight into the pathophysiology of hearing loss. The ECoG response is evoked using an acoustic stimulus and includes contributions from the hair cells (cochlear microphonic-CM) as well as the auditory nerve (auditory nerve neurophonic-ANN). Seven Hybrid L24 CI users with complete loss of residual hearing months after surgery underwent ECoG measures before and after loss of hearing. While significant reductions in CMs were evident after hearing loss, all participants had measurable CMs despite having no measurable acoustic hearing. None retained measurable ANNs. Given histological data suggesting stable hair cell and neural counts after hearing loss (e.g., Quesnel et al. Hear Res. 333:225-234. (2016)), the loss of ECoG and audiometric hearing may reflect reduced synaptic input. This is consistent with the theory that residual CM responses coupled with little to no ANN responses reflect a "disconnect" between hair cells and auditory nerve fibers (Fontenot et al. Ear Hear. 40(3):577-591. 2019). This "disconnection" may prevent proper encoding of auditory stimulation at higher auditory pathways, leading to a lack of audiometric responses, even in the presence of viable cochlear hair cells.

Factors Influencing Speech Perception in Adults With a Cochlear Implant.

The primary objective of this study is to identify the biographic, audiologic, and electrode position factors that influence speech perception performance in adult cochlear implant (CI) recipients implanted with a device from a single manufacturer. The secondary objective is to investigate the independent association of the type of electrode (precurved or straight) with speech perception. In a cross-sectional study design, speech perception measures and ultrahigh-resolution computed tomography scans were performed in 129 experienced CI recipients with a postlingual onset of hearing loss. Data were collected between December 2016 and January 2018 in the Radboud University Medical Center, Nijmegen, the Netherlands. The participants received either a precurved electrode (N = 85) or a straight electrode (N = 44), all from the same manufacturer. The biographic variables evaluated were age at implantation, level of education, and years of hearing loss. The audiometric factors explored were preoperative and postoperative pure-tone average residual hearing and preoperative speech perception score. The electrode position factors analyzed, as measured from images obtained with the ultrahigh-resolution computed tomography scan, were the scalar location, angular insertion depth of the basal and apical electrode contacts, and the wrapping factor (i.e., electrode-to-modiolus distance), as well as the type of electrode used. These 11 variables were tested for their effect on three speech perception outcomes: consonant-vowel-consonant words in quiet tests at 50 dB SPL (CVC50) and 65 dB SPL (CVC65), and the digits-in-noise test. A lower age at implantation was correlated with a higher CVC50 phoneme score in the straight electrode group. Other biographic variables did not correlate with speech perception. Furthermore, participants implanted with a precurved electrode and who had poor preoperative hearing thresholds performed better in all speech perception outcomes than the participants implanted with a straight electrode and relatively better preoperative hearing thresholds. After correcting for biographic factors, audiometric variables, and scalar location, we showed that the precurved electrode led to an 11.8 percentage points (95% confidence interval: 1.4-20.4%; p = 0.03) higher perception score for the CVC50 phonemes compared with the straight electrode. Furthermore, contrary to our initial expectations, the preservation of residual hearing with the straight electrode was poor, as the median preoperative and the postoperative residual hearing thresholds for the straight electrode were 88 and 122 dB, respectively. Cochlear implantation with a precurved electrode results in a significantly higher speech perception outcome, independent of biographic factors, audiometric factors, and scalar location.

Clinical Utility of Intraoperative Electrocochleography (ECochG) During Cochlear Implantation: A Systematic Review and Quantitative Analysis.

To evaluate the utility of intraoperative electrocochleography (ECochG) as a predictive tool for preservation of residual acoustic hearing after cochlear implantation. A systematic review employing a multi-database search strategy (Ovid MEDLINE, Embase, EBM Cochrane, and Scopus) was conducted from inception to August 1, 2019. English language studies in humans were included. All articles were independently reviewed by two authors according to Preferred Reporting Items of Systematic Reviews and Meta-analysis (PRISMA) guidelines. Studies without intraoperative ECochG obtained during cochlear implantation were excluded. Extracted variables included number of patients, ECochG recording technique, success rate of obtaining ECochG potentials, intraoperative changes in ECochG signal, and postoperative hearing preservation outcomes. Among 537 eligible articles, 22 met inclusion criteria encompassing 498 unique patients. Ten studies featured extracochlear measurements, eight featured intracochlear measurements, and four featured both. Extracochlear ECochG had an average (SD) recording success rate of 94.9% (12.7%) while intracochlear ECochG had an average (SD) recording success rate of 91.8% (9.8%). One hundred forty five unique patients from six studies had complete intraoperative ECochG data with postoperative behavioral audiometry. After accounting for study-specific definitions of ECochG signal disturbance, worsening changes in intraoperative ECochG signal predicted postoperative hearing loss with limited sensitivity and specificity and notable heterogeneity across studies. Intraoperative ECochG recordings can be obtained in over 90% of patients, but accuracy in predicting postoperative hearing loss remains limited. Standardization of intraoperative ECochG monitoring technique and data interpretation are necessary to more robustly investigate outcomes and refine technique.

A New CT Parameter for Predicting Residual Hearing Preservation in Cochlear Implantation: The "Basal Turn-Facial Ridge Angle".

We suggest a simple measurement, called the "basal turn-facial ridge (BT-FR) angle," for determining the electrode insertion axis using preoperative temporal bone computed tomography (CT) to predict hearing preservation (HP) in cochlear implantation (CI). Retrospective chart review. Tertiary referral center. Eighty-two ears that underwent CI between 2010 and 2018 were included. Ears with preoperative thresholds less than or equal to 80 dB HL at 125, 250, and 500 Hz were enrolled and grouped using the criteria of Skarżyński et al.: Group 1, complete or partial HP; Group 2, minimal HP or complete hearing loss. All subjects underwent CI with soft surgery techniques through the round window approach. The BT-FR angle is the angle between the basal turn line (BT-line), which is a straight line passing through the center of the longitudinal axis of the BT, and the facial ridge line, which is a straight line running from the endpoint of the BT-line to a point just above the facial ridge. The BT-FR angle was 2.5 ± 2.9 degrees in Group 1 and -0.3 ± 2.7 degrees in Group 2 (p = 0.003). The angle and hearing loss showed a significant negative correlation (r = -0.401, p = 0.002). In multiple linear regression, "age at operation" (β coefficient 0.260; p = 0.001) and the "BT-FR angle" (-1.967; p = 0.001) were significant variables affecting the degree of residual hearing loss. The BT-FR angle, which can be measured simply, may be useful to predict residual HP after CI.

Effect of Underwater Insertion on Intracochlear Pressure

Background: The importance of intracochlear pressure during cochlear electrode insertion for the preservation of residual hearing has been widely discussed. Various aspects of pre-insertional, intra-insertional, and post-insertional relevant conditions affect intracochlear pressure. The fluid situation at the round window during electrode insertion has been shown to be an influential factor.Aims/Objectives: The aim of the study was to compare various insertion techniques in terms of the fluid situation at the round window.Material and Methods: We performed insertion of cochlear implant electrodes in a curled artificial cochlear model. We placed and fixed the pressure sensor at the tip of the cochlea. In parallel to the insertions, we evaluated the maximum amplitude of intracochlear pressure under four different fluid conditions at the round window: (1) hyaluronic acid; (2) moisturized electrode, dry middle ear; (3) middle ear filled with fluid (underwater); and (4) moisturized electrode, wet middle ear, indirectly inserted.Results: We observed that the insertional intracochlear pressure is dependent on the fluid situation in front of the round window. The lowest amplitude changes were observed for the moisturized electrode indirectly inserted in a wet middle ear (0.13 mmHg ± 0.07), and the highest values were observed for insertion through hyaluronic acid in front of the round window (0.64 mmHg ± 0.31).Conclusions: The fluid state in front of the round window influences the intracochlear pressure value during cochlear implant electrode insertion in our model. Indirect insertion of a moisturized electrode through a wet middle ear experimentally generated the lowest pressure values. Hyaluronic acid in front of the round window leads to high intracochlear pressure in our non-validated artificial model.

Neuroprotective Effect of Near-Infrared Light in an Animal Model of CI Surgery

Introduction: The preservation of residual hearing has become an important consideration in cochlear implant (CI) recipients in recent years. It was the aim of the present animal experimental study to investigate the influence of a pretreatment with near-infrared (NIR) light on preservation of sensory hair cells and residual hearing after cochlear implantation. Methods: NIR was applied unilaterally (15 min, 808 nm, 120 mW) to 8 guinea pigs, immediately before a bilateral scala tympani CI electrode insertion was performed. The nonirradiated (contralateral) side served as control. Twenty-eight days postoperatively, auditory brainstem responses (ABRs) were registered from both ears to screen for hearing loss. Thereafter, the animals were sacrificed and inner hair cells (IHCs) and outer hair cells (OHCs) were counted and compared between NIR-pretreated and control (contralateral) cochleae. Results: There was no IHC loss upon cochlear implantation. OHC loss was most prominent on both sides at the apical part of the cochlea. NIR pretreatment led to a statistically significant reduction in OHC loss (by 39.8%). ABR recordings (across the frequencies 4–32 kHz) showed a statistically significant difference between the 2 groups and corresponds well with the apical structural damage. Hearing loss was reduced by about 20 dB on average for the NIR-pretreated group (p ≤ 0.05). Discussion/Conclusion: A single NIR pretreatment in this animal model of CI surgery appears to be neuroprotective for residual hearing. This is in line with other studies where several NIR posttreatments have protected cochlear and other neural tissues. NIR pretreatment is an inexpensive, effective, and noninvasive approach that can complement other ways of preserving residual hearing and, hence, should deserve further clinical evaluation in CI patients.

Do Impedance Changes Correlate With a Delayed Hearing Loss After Hybrid L24 Implantation?

Preservation of residual hearing is one of the main goals in present cochlear implantation surgery. Especially for this purpose, smaller and softer electrode carriers were developed that are to be inserted through the round window membrane to minimize trauma. By using these electrodes and insertion technique, residual hearing can be preserved in a large number of patients. Unfortunately, some of these patients with initially preserved residual hearing after cochlear implantation lose it later on. The reason for this is unknown but it is speculated about a correlation with an increase in impedance, since increased impedance values are linked to intracochlear inflammation and tissue reaction. Our hypothesis for this study design was that an increase in impedance predicts changes in residual hearing under clinical conditions. Data of all adult patients (N = 122) receiving a Hybrid-L24 cochlear implant at our center between 2005 and early 2015 were retrospectively evaluated. Impedance values in Common Ground mode as measured during clinical routine and referring audiological test data (audiometric thresholds under headphones) were collected. Changes between consecutive measurements were calculated for impedance values and hearing thresholds for each patient. Correlations between changes in impedances and acoustic hearing thresholds were calculated. Average values were compared as well as patients with largest impedance changes within the observation period were evaluated separately. Group mean values of impedances were between 5 and 7 kΩ and stable over time with higher values on basal electrode contacts compared with apical contacts. Average hearing thresholds at the time of initial fitting were between 40 to 50 dB (250 Hz) and 90 dB (1 kHz) with a loss of about 10 dB compared with preoperative values. Correlation between impedance changes and threshold changes was found, but too inconsistently to imply a true relationship. When evaluating the 20 patients with the largest impedance changes during the observation period (all >1 kΩ from one appointment to the next one), some patients were found where hearing loss is timely connected and highly correlated with an unusual impedance change. But large impedance changes were also observed without affecting hearing thresholds and hearing loss was found without impedance change. Changes in impedance as measured during clinical routine cannot be taken as an indicator for a late acoustic hearing loss.

Randomized placebo-controlled clinical trial investigating the effect of antioxidants and a vasodilator on overall safety and residual hearing preservation in cochlear implant patients

BackgroundThe standard therapy for patients suffering from sensorineural hearing loss is cochlear implantation. The insertion of the electrode array into the cochlea, with potential mechanical trauma and the presence of this foreign body inside the cochlea, may lead to free radical formation and reduced blood perfusion of the cochlea which can result in a loss of residual hearing. Studies have suggested that a particular combination of the antioxidants vitamins A, C and E as well as the vasodilator magnesium (together: ACEMg) may protect the residual hearing.MethodsThe potential protective effect of ACEMg on residual hearing preservation in cochlear implant (CI) patients was investigated in a single-centre, randomized, placebo-controlled, double-blind phase II clinical trial. CI candidates with some residual hearing in low frequencies receiving MED-EL implants of different FLEX electrode array lengths were treated with ACEMg tablets or placebo respectively 2 days preoperatively and up to 3 months postoperatively. The study objective was to demonstrate that ACEMg is more efficacious than placebo in preserving residual hearing during cochlear implantation by comparing the hearing loss (change in hearing thresholds at 500 Hz from baseline) 3 months after the first fitting between the two treatment groups and to investigate the treatments’ safety.ResultsFifty-one patients were included in the study, which had to be terminated before the recruitment goal was reached because of IMP-resupply mismanagement of one partner. In the intention-to-treat population, 25 patients were treated with ACEMg and 24 patients with placebo. The mean hearing loss at 500 Hz was (± 15.84) 30.21 dB (placebo) or (± 17.56) 26.00 dB (ACEMg) 3 months after the initial fitting. Adjusting the postoperative hearing loss for the baseline residual hearing, planned electrode length and surgeon results in 8.01 dB reduced hearing loss in ACEMg-treated patients compared to placebo-treated ones. The safety analysis revealed that ACEMg was generally well-tolerated with adverse event frequencies below the placebo level.ConclusionThis is the first clinical trial investigating a drug effect on residual hearing in CI patients. These first-in-man data may suggest that a perioperative oral administration of ACEMg is safe and may provide protection of residual hearing in CI patients.Trial registrationEU Clinical Trial Register No. 2012-005002-22. Registered on 6 December 2013. Funding: European Commission FP7-HEALTH-2012-INNOVATION-2.

Hearing Preservation Outcomes With Standard Length Electrodes in Adult Cochlear Implantation and the Uptake of Electroacoustic Stimulation.

Cochlear implantation with preservation of residual low-frequency hearing enables patients to utilize acoustic and electrical stimulation. It is widely accepted that preservation of residual low-frequency hearing is beneficial in both background noise and for music appreciation. The extent to which patients may benefit is not fully understood, but the importance of these concepts is reflected in electrode design developments and also refinement of surgical technique. Greater understanding is needed around factors that may affect hearing preservation. This study reports experience in adults using standard length cochlear implant arrays. The study reviews hearing preservation outcomes using the HEARRING GROUP method for factors such as gender, electrode type, insertion depth, laterality, preoperative hearing level, and time between surgery and audiogram. Furthermore, the study reviews rates of electroacoustic stimulation use in those with postoperative functional residual low-frequency hearing. Retrospective case series. preoperative ≤ 85 dB HL at 250 Hz and aged ≥ 18 years. The hearing preservation percentages were calculated using the HEARRING group formula S=[1 - ((PTApost - PTApre)/(PTAmax - PTApre))*100]%. Preservation of > 75% was considered complete, 25 to 75% partial, and 1 to 25% minimal. Standardized operative technique with facial recess approach, posterior tympanotomy, and minimally traumatic round window insertion was performed for each implant. Fifty-three implantations in 52 patients met the inclusion criteria. The mean age at implantation was 55.5 years. The average time since the last audiogram was 10 months. The mean average total pre and postoperative pure-tone averages were 92.4 dB, 99.2 dB, respectively, using minimum reporting standards for adult cochlear Implant (CI). Thirty percent demonstrated complete hearing preservation, 35.8% partial hearing preservation, and 20.8% minimal hearing preservation. Overall, mean hearing preservation was 52.9%. Sex, age at implantation, insertion depth, lateral versus perimodiolar electrode, and preoperative hearing level did not statistically significantly affect rates of hearing preservation in our study. There was a statistically significant deterioration in hearing preservation outcomes difference at 3 months compared with 12 months postoperatively. Only two patients within our study out of 17 with functional postoperative hearing went on to use electroacoustic stimulation. Hearing preservation varies between patients and postoperative outcomes are difficult to predict. This study adds to existing literature in terms of likelihood of hearing preservation following cochlear implantation. In turn, this improves our ability to counsel patients as to the chances of preserving residual low-frequency hearing postoperatively and their ability to use electroacoustic stimulation.

Cochlear implantation and residual hearing preservation long-term follow-up of the first consecutively operated patients using the round window approach in Uppsala, Sweden

Objective: We conducted a long-term follow-up study to investigate the time course of residual hearing in our first 21 consecutively operated cochlear implant (CI) patients using the round window (RW) approach . The study may provide additional information about the influence of a flexible lateral wall electrode array on cochlear function. Methods: Data were available for long-term follow-up (>5 years) in 15 patients. Pure tone audiometry (PTA) was assessed at 0.125–8 kHz preoperatively, and at one, three and >5 years postoperatively. Insertion angle, number of electrodes inside the cochlea, user-time of the processor and stimulation strategy were documented. Results: Twelve out of 15 patients had residual hearing after a follow-up period of five years (mean 86 months, range: 61–103 months). Four out of 15 patients had >75% complete hearing preservation (HP), 8 out of 15 had 25–75% partial HP and 3 out of 15 patients had complete loss of hearing. There was a high correlation between insertion angle and HP. Conclusion: Long-term HP was possible in 12 out of 15 cases. Even patients with complete hearing loss at long-term follow-up showed high performance in speech understanding and were full-time users.

Long-term Hearing Preservation in Electric Acoustic Cochlear Implant Candidates.

To evaluate long-term stability and residual hearing preservation after cochlear implantation with electric acoustic stimulation (EAS). Retrospective chart-analysis. University clinic. Long- and short-term hearing preservation (HP) of 18 EAS subjects (21 ears) was evaluated. Short-term was defined as follow-ups less than 12 months after surgery versus long-term outcomes longer than 12 months postsurgery. Mean period of observation in the short-term group was 4 ± 3.0 months (range 0-7). In the long-term group the mean follow-up was 28.4 ± 15.0 months (range 12-58). Full insertion was possible in all 18 implanted subjects. In the short-term group, complete HP was achieved in 50%, partial HP in 33.3%, and minimal HP in 8.3% of the investigated subjects. One subject lost hearing completely. In the long-term group, complete HP was achieved in 50%, partial HP was observed in 40%, and minimal HP in 10% of the ears. No subject lost hearing completely. Subjects using EAS showed better word recognition scores after surgery (mean at 65 dB 55.3 ± 18.4; mean at 80 dB 68.1 ± 12.2) than subjects using electric stimulation only (mean at 65 dB 38.3 ± 18.1; mean at 80 dB 60.0 ± 16.4) with nonfunctional low-frequency hearing. The study confirms that hearing can be preserved to a large extent. As a result, most subjects benefitted from EAS. Subjects with postoperative functional low-frequency hearing showed greater benefit in word speech tests. Furthermore, the outcomes show that EAS implantation is a safe, effective, and most importantly stable treatment option (longest follow-up with 58 mo).

Genetic testing has the potential to impact hearing preservation following cochlear implantation

Background: Recent advances in less-invasive surgery and electrode design allow for a high degree of hearing preservation (HP) after cochlear implantation (CI), although residual hearing still deteriorates in some patients. To date, the factors predictive of preserving residual hearing remain a controversial topic.Objective: The aim of this study was to investigate the predictive factors, including the etiology of hearing loss (HL) as a patient-related factor, influencing residual HP after CI.Methods: Forty-four patients (50 ears, 41 families) with residual acoustic hearing who underwent CI were included. Auditory thresholds before and at 6 months after initial activation were measured. Genetic testing was performed to identify the responsible genes for HL.Results: We identified the cause of HL in 21 families (51.2%). HP was marginally correlated with age at implantation, while it was independent of pre-operative low-frequency hearing thresholds, cochlear duct length, and electrode length. We found that patients who had pathogenic variants in the CDH23, MYO7A, or MYO15A gene showed statistically better HP scores compared with patients with HL due to other causes (p = .002).Conclusions: Identification of the etiology of HL using genetic testing is likely to facilitate the prediction of HP after implant surgery.