Suitable Electrode Choice for Robotic-Assisted Cochlear Implant Surgery: A Systematic Literature Review of Manual Electrode Insertion Adverse Events

BACKGROUND AND OBJECTIVE: The cochlear implant (CI) electrode insertion process is a key step in CI surgery. One of the aims of advances in robotic-assisted CI surgery (RACIS) is to realize better cochlear structure preservation and to precisely control insertion. The aim of this literature review is to gain insight into electrode selection for RACIS by acquiring a thorough knowledge of electrode insertion and related complications from classic CI surgery involving a manual electrode insertion process. METHODS: A systematic electronic search of the literature was carried out using PubMed, Scopus, Cochrane, and Web of Science to find relevant literature on electrode tip fold over (ETFO), electrode scalar deviation (ESD), and electrode migration (EM) from both pre-shaped and straight electrode types. RESULTS: A total of 82 studies that include 8,603 ears implanted with a CI, i.e., pre-shaped (4,869) and straight electrodes (3,734), were evaluated. The rate of ETFO (25 studies, 2,335 ears), ESD (39 studies, 3,073 ears), and EM (18 studies, 3,195 ears) was determined. An incidence rate (±95% CI) of 5.38% (4.4–6.6%) of ETFO, 28.6% (26.6–30.6%) of ESD, and 0.53% (0.2–1.1%) of EM is associated with pre-shaped electrodes, whereas with straight electrodes it was 0.51% (0.1–1.3%), 11% (9.2–13.0%), and 3.2% (2.5–3.95%), respectively. The differences between the pre-shaped and straight electrode types are highly significant (p < 0.001). Laboratory experiments show evidence that robotic insertions of electrodes are less traumatic than manual insertions. The influence of round window (RW) vs. cochleostomy (Coch) was not assessed. CONCLUSION: Considering the current electrode designs available and the reported incidence of insertion complications, the use of straight electrodes in RACIS and conventional CI surgery (and manual insertion) appears to be less traumatic to intracochlear structures compared with pre-shaped electrodes. However, EM of straight electrodes should be anticipated. RACIS has the potential to reduce these complications

Electrically evoked compound action potentials are different depending on the site of cochlear stimulation.

One of the many parameters that can affect cochlear implant (CI) users' performance is the site of presentation of electrical stimulation, from the CI, to the auditory nerve. Evoked compound action potential (ECAP) measurements are commonly used to verify nerve function by stimulating one electrode contact in the cochlea and recording the resulting action potentials on the other contacts of the electrode array. The present study aimed to determine if the ECAP amplitude differs between the apical, middle, and basal region of the cochlea, if double peak potentials were more likely in the apex than the basal region of the cochlea, and if there were differences in the ECAP threshold and recovery function across the cochlea. ECAP measurements were performed in the apical, middle, and basal region of the cochlea at fixed sites of stimulation with varying recording electrodes. One hundred and forty one adult subjects with severe to profound sensorineural hearing loss fitted with a Standard or FLEX(SOFT) electrode were included in this study. ECAP responses were captured using MAESTRO System Software (MED-EL). The ECAP amplitude, threshold, and slope were determined using amplitude growth sequences. The 50% recovery rate was assessed using independent single sequences that have two stimulation pulses (a masker and a probe pulse) separated by a variable inter-pulse interval. For all recordings, ECAP peaks were annotated semi-automatically. ECAP amplitudes were greater upon stimulation of the apical region compared to the basal region of the cochlea. ECAP slopes were steeper in the apical region compared to the basal region of the cochlea and ECAP thresholds were lower in the middle region compared to the basal region of the cochlea. The incidence of double peaks was greater upon stimulation of the apical region compared to the basal region of the cochlea. This data indicates that the site and intensity of cochlear stimulation affect ECAP properties

Fibroblast Growth Factor 2—A Review of Stabilisation Approaches for Clinical Applications

Basic fibroblast growth factor (FGF)-2 has been shown to regulate many cellular functions including cell proliferation, migration, and differentiation, as well as angiogenesis in a variety of tissues, including skin, blood vessel, muscle, adipose, tendon/ligament, cartilage, bone, tooth, and nerve. These multiple functions make FGF-2 an attractive component for wound healing and tissue engineering constructs; however, the stability of FGF-2 is widely accepted to be a major concern for the development of useful medicinal products. Many approaches have been reported in the literature for preserving the biological activity of FGF-2 in aqueous solutions. Most of these efforts were directed at sustaining FGF-2 activity for cell culture research, with a smaller number of studies seeking to develop sustained release formulations of FGF-2 for tissue engineering applications. The stabilisation approaches may be classified into the broad classes of ionic interaction modification with excipients, chemical modification, and physical adsorption and encapsulation with carrier materials. This review discusses the underlying causes of FGF-2 instability and provides an overview of the approaches reported in the literature for stabilising FGF-2 that may be relevant for clinical applications. Although efforts have been made to stabilise FGF-2 for both in vitro and in vivo applications with varying degrees of success, the lack of comprehensive published stability data for the final FGF-2 products represents a substantial gap in the current knowledge, which has to be addressed before viable products for wider tissue engineering applications can be developed to meet regulatory authorisation

Restoration of cortical symmetry and binaural function: Cortical auditory evoked responses in adult cochlear implant users with single sided deafness.

BACKGROUND:Cochlear implantation for single-sided deafness (SSD) is the only treatment option with the potential to restore binaural hearing cues. Significant binaural benefit has been measured in adults by speech in noise and localisation tests, who receive a cochlear implant for SSD, however, little is known on the cortical changes that help provide this benefit. In the present study, detection of sound in the auditory cortex, speech testing and localisation was used to investigate the ability of a cochlear implant (CI) to restore auditory cortical latencies and improve binaural benefit in the adult SSD population. METHODS:Twenty-nine adults with acquired single-sided deafness who received a CI in adulthood were studied. Speech perception in noise was tested using the Bamford-Kowal-Bench speech-in-noise test, localisation ability was measured using the auditory speech sounds evaluation (AδE) localisation test and cortical auditory evoked responses, comparing N1-P2 latencies recorded from the normal hearing ear and cochlear implant were used to investigate the synchrony of the cortical pathway from the CI and normal hearing ear (NHe) with binaural hearing function. RESULTS:There was a significant improvement in speech perception in noise in all spatial configurations S0/N0 (Z = -3.066, p<0.002), S0/NHE (Z = -4.031, p<0.001), SCI/NHE (Z = -3.851, p<0.001). Localization significantly improved when tested with the cochlear implant on (p<0.001) with a shorter duration of deafness correlating to a greater improvement in localisation ability F(1:18) = 6.854; p = 0.017). There was no significant difference in N1-P2 latency recorded from the normal hearing ear and the CI. CONCLUSION:Cortical auditory evoked response latencies recorded from the CI and NHe showed no significant difference, indicating that the detection of sound in the auditory cortex occurred simultaneously, providing the cortex with auditory information for binaural hearing

Stabilisation of Recombinant Human Basic Fibroblast Growth Factor (FGF-2) against Stressors Encountered in Medicinal Product Processing and Evaluation

Basic fibroblast growth factor (FGF-2) is a highly labile protein with strong potential for tissue engineering. The aim of this study was to develop FGF-2 formulations that are stable against physical stressors encountered in pharmaceutical processing and evaluation. Pharmaceutical excipients, alone or in combination, were added to aqueous FGF-2 (770 ng/mL) solution and the stability of the resulting solutions on storage at 4–37 °C was evaluated. Stability of the solutions to repeated freeze-thaw cycles and lyophilisation was also evaluated, as well as the stability of the lyophilised stabilised protein to storage at −4, 4 and 18 °C for up to 12 months. In all of these experiments FGF-2 was quantified by ELISA assay. The as-received FGF-2, when dissolved in water, was highly unstable, retaining only 50% of baseline protein content after 30 min at 37 °C or 1 h at 25 °C. By contrast, FGF-2 solutions prepared with 0.5% w/v methylcellulose (MC) and 20 mM alanine (formulation F5) or with 0.5% w/v MC and 1 mg/mL human serum albumin (HSA) (formulation F6) were highly stable, having residual FGF-2 content comparable to baseline levels even after 2 h at 37 °C and 5 h at 25 °C. F5 and F6 were also highly stable to repeated freeze-thaw cycles, with >99% of FGF-2 load remaining after the third cycle. In addition, F5 and F6 were stable to lyophilisation, and the lyophilised products could be stored at −4, 4 or 18 °C for at least 12 months, with less than 1% loss in mean FGF-2 content. Thus, FGF-2 solution is effectively stabilised against both thermal and processing stressors in the presence of MC and alanine (F5), or MC and HSA (F6). The resultant FGF-2 solutions may be applied as medicinal products or further processed into more advanced medicinal products, e.g., scaffolds, for wound healing and tissue regeneration

Successful outcomes of cochlear implantation in long-term unilateral deafness : brain plasticity?

To investigate the implications of duration of deafness in the rehabilitation of unilateral deafness utilizing cochlear implantation. From the ongoing prospective cochlear implantation in unilateral deafness study, we looked at five adults who received a cochlear implant for long-term unilateral deafness. Speech perception in noise and subjective evaluation of the benefits of cochlear implantation were measured at 3, 6, and 12 months after implantation. The results were analyzed and compared with published data from normal hearing individuals and adults using cochlear implants bilaterally. Analysis of speech perception in noise showed significant improvement for three spatial configurations: speech and noise from the front (S0/N0; P=0.003), speech from the front and noise from the normal hearing ear (S0/NHE; P=0.001), speech from the implanted ear, and noise from the normal hearing ear (SCI/NHE; P<0.001). The scores obtained at 12 months after surgery improved to values similar to those obtained by individuals with normal hearing. The results of subjective measures showed significant improvement in hearing over time to the scores obtained by individuals with a bilateral cochlear implants and those with normal hearing. In this study, older adults with more than 25 years of unilateral deafness obtained scores in speech perception testing and in subjective evaluation that are similar to those attained by individuals with normal hearing and/or those with bilateral cochlear implants. Therefore, patients with postlingual unilateral deafness should not be excluded as cochlear implant candidates on the basis of a long duration of deafness.6 page(s