Impact of electrode insertion depth on intracochlear trauma.

OBJECTIVE: To assess the effect of cochlear implant (CI) insertion depth and surgical technique on intracochlear trauma. STUDY DESIGN AND SETTING: Twenty-one fresh human temporal bones were implanted with CI electrodes and underwent histologic processing and evaluation. Specimens were grouped into 3 categories: 1) soft implantation technique and standard electrode; 2) soft implantation technique and flexible prototype array; 3) forceful implantations and standard electrode. Based on the grading system (1 to 4), 2 numeric values were calculated indicating the overall severity of cochlear damage (trauma indices). RESULTS: Mean trauma index values were 13.8, 36.3, and 59.2 for group 1, 2, and 3, respectively. Differences in cochlear trauma (trauma index) were nonsignificant between specimens in groups 1 and 2 but were significant between groups 1 and 3. CONCLUSION: This study gives evidence that intracochlear trauma increases with deep insertions. Thus, in cases where cochlear integrity might be important, limited insertions should be achieved.

[Evaluation of the insertion-trauma of the Nucleus Contour Advance electrode-array in a human temporal bone model]. / Evaluation des Insertionstraumas des Nucleus Contour Advance-Elektrodenträgers im humanen Felsenbeinmodell.

BACKGROUND: The development of intracochlear electrode arrays is aiming at a placement close to the modiolus with an insertion as atraumatic as possible. A new perimodiolar electrode model the Nucleus Contour Advance was to be evaluated regarding the possible intracochlear trauma. METHODS: The implantation of the Contour Advance electrode was performed in 11 frozen native temporal bones. Beneath a regular insertion in 5 temporal bones in 6 cases the insertion was carried out using the "advance-off-stylett" technique with a fixed stylett. The temporal bones were embedded in metacrylate based resin for histomorphological evaluation. The evaluation was performed regarding to the intracochlear placement close to the modiolus and the damage to intracochlear fine structures (basilar membrane, osseus spiral lamina). RESULTS: In 2 out of 11 cases we found a perforation from the scala tympani to the scala vestibuli independent of the insertion-technique. A severe intracochlear trauma was observed in one case with fracture of osseus spiral lamina using the AOS-technique. A close position to the modiolus could be achieved by insertion the scala tympani without perforation of the basilar membrane. CONCLUSIONS: The Nucleus Contour Advance electrode array showed minimal trauma in human temporal bones by using a standard insertion technique. By using the freehand AOS-technique a severe cochlear trauma is possible. Therefore further development in electrode design and the use of an insertion-tool is recommended.

Evaluation of the HiFocus electrode array with positioner in human temporal bones.

The aim of the study presented was to assess the insertion mode and possible intracochlear trauma after implantation of the HiFocus electrode with positioner in human temporal bones. The study was performed in five freshly frozen temporal bones. The position of electrodes was evaluated using conventional X-ray analysis, rotational tomography and histomorphological analysis. Insertion of the HiFocus electrode with positioner resulted in considerable trauma to fine cochlear structures including fracture of the osseous spiral lamina, dislocation of the electrode array from the scala tympani into the scala vestibuli and fracture of the modiolus close to the cochleostomy. The implication of the results regarding clinical outcome will be discussed.

Comparative study of cochlear damage with three perimodiolar electrode designs.

OBJECTIVE: To describe intracochlear insertion trauma caused by three perimodiolar cochlear implant electrodes. STUDY DESIGN: Descriptive histological study of 15 human cadaver temporal bones. METHODS: Fifteen cadaver temporal bones underwent surface preparation and were implanted with one of the following perimodiolar electrode arrays: Combi 40+PM (MedEl Corporation), HiFocus II (Advanced Bionics Corporation), or Contour (Cochlear Corporation). A cryosectioning technique was used to study horizontal sections at 200 microm intervals with the electrode in place. Image-enhanced videofluoroscopy and computer-assisted morphometrics were used to assess the mechanism of insertion trauma and to determine electrode position within the modiolus. RESULTS: Histological examination revealed varying degrees of damage to the spiral ligament, basilar membrane, and osseous spiral lamina. Using a novel grading system for electrode trauma, there was no statistically significant difference among the three electrodes. A literature search of histological studies of a commonly used "standard" electrode showed damage equal to or greater than that seen in the current study. CONCLUSIONS: Insertion trauma caused by periomodiolar electrodes occurs to an acceptable degree. Refinement of electrodes based on mechanisms of trauma may be able to further reduce damage.

Clarion 1.2 standard electrode array with partial space-filling positioner: radiological and histological evaluation in human temporal bones.

The purpose of this study was to evaluate whether use of a positioner for situating the Clarion 1.29 standard electrode array in close proximity to the modiolus, causes damage to fine intra-cochlear structures, and to provide a comparison with results obtained for insertions of the array performed without a positioner. The study was performed in seven freshly frozen human temporal bones. Electrode location and intra-cochlear trauma was analysed using cross-sectional imaging and histological analysis. Insertion of the Clarion array did not reveal major trauma. The devices inserted with the positioner showed a consistently closer location of the electron array towards the modiolus, however, insertion resulted in significant displacement of both the electrode array and the positioner resulting in severe destruction of the basilar membrane and osseous spiral lamina along the length of the basal and middle turns. The devices inserted with the positioner resulted in major trauma to the basilar membrane and osseous spiral lamina. Therefore, systematic safety studies in larger samples of human temporal bones should be performed and the results carefully evaluated before implantation can be recommended unreservedly.

Insertional trauma of multichannel cochlear implants.

Insertional trauma to the cochlea from three different multichannel cochlear implant electrodes was evaluated in a single-blind controlled study in fresh human temporal bones. Sixteen fresh human temporal bones were implanted with one of three types of multichannel electrodes (Symbion/InnerAid, Cochlear/Nucleus, or Storz/UCSF). Seven temporal bones were used as controls where a cochleostomy only was created. The temporal bones were evaluated histologically and cochlear histograms of the trauma were created. Although the three electrode designs caused damage which was unlikely to hinder implant performance, a distinct pattern of trauma was seen with each of the three electrode types. The least traumatic of the three electrode designs in this study was the Nucleus type. The degree of insertional trauma may be relevant to changing indications for insertion of cochlear implants as well as for patients with device failure who require reimplantation.

Cochlear damage in guinea pigs following contralateral sound stimulation with and without gentamicin.

The effect of a minimally damaging sound exposure and a sub-ototoxic dose of gentamicin on cochlear hair cells contralateral to the sound exposure was evaluated. The cochleae of pigmented guinea pigs exposed to an 8 kHz pure tone at 116 dB SPL for 1 h and/or 50 mg/kg/day of gentamicin for 10 consecutive days and repeated after an interval of 3 weeks, were used for this purpose. Hair cell loss was found to have occurred in the contralateral cochleae following the sound exposure alone. The occurrence of potentiation, synergism and differential synergism between the agents in the contralateral ears was also seen. Possible explanations for these phenomena are proposed.

Banded intracochlear electrode array: evaluation of insertion trauma in human temporal bones.

A banded free-fit scala tympani array was inserted into the basal turn of nine human cochleas to evaluate the trauma produced by the procedure. These nine cochleas, together with five nonimplanted controls, were serially sectioned and examined microscopically for damage to the membranous labyrinth, in particular the spiral ligament, the basilar and Reissner's membranes, the stria vascularis, and the osseous spiral lamina. The severity and location of any trauma along the cochlear spiral were recorded. The results indicate that the insertion of the banded scala tympani array resulted in minimal mechanical damage, occurring primarily to a localized region of the spiral ligament. This would not result in significant neural degeneration, and therefore would not compromise the efficacy of the multichannel cochlear prosthesis.

Comparison of cochlear histopathology following two implant designs for use in scala tympani.

Two designs of intracochlear implants were evaluated for their histopathologic effects in the monkey ear. A molded electrode designed to fit the contour of the basal turn of the scala tympani tended to create basilar membrane fistulas and osseous spiral lamina fracture, along with relatively extensive loss of spiral ganglion cells in sites adjacent to the implant. A delicate, free-fit electrode induced local encapsulation but little or no mechanical damage and limited degeneration of spiral ganglion cells. Both electrode types occasionally induced changes in stria vascularis.