In vitro and in vivo pharmacokinetic study of a dexamethasone-releasing silicone for cochlear implants.

Cochlear implants have been widely used for patients with profound hearing loss and partial deafness. Residual low-frequency hearing, however, may deteriorate due to insertion trauma and tissue response around the electrode array. The present study investigated in vitro and in vivo release of dexamethasone from silicone used for cochlear implant electrode carriers. The in vitro experiment involved an apparatus simulating the inner ear fluid environment in humans. Release from two sizes of silicone films (200 µm × 1 mm × 10 mm and 500 µm × 1 mm × 10 mm), each loaded with 2 % dexamethasone, and was measured for 24 weeks. In the in vivo experiment, silicone rods loaded with 2 or 10 % dexamethasone, respectively, were implanted into the scala tympani of guinea pigs. Perilymph concentrations were measured during the first week after implantation. The results showed that dexamethasone was released from the silicone in a sustained manner. After a burst release, perilymph concentration was similar for silicone incorporated with 2 and 10 % dexamethasone, respectively. The similar pharmacokinetic profile was found in the in vitro experiment. The period of sustained drug delivery was maintained for 20 weeks in vitro and for 1 week in vivo. The results of the present study suggest that drugs like dexamethasone are released in a controlled manner from silicon electrode carriers of cochlear implants. Further studies will identify optimal release profiles for the use with cochlear implants to improve their safety and long-term performance.

Influence of a totally open oval window on bone conduction in otosclerosis.

OBJECTIVE: The aim of this study was to evaluate changes in bone conduction thresholds before, during and after total stapedectomy. STUDY DESIGN: Prospective clinical study. METHODS: In 27 ears of 26 patients undergoing stapedectomy under local anesthesia, bone conduction was measured before surgery, during surgery under open oval window conditions, and after the insertion of a steel wire connective tissue prosthesis. Statistical data analysis was performed on the audiometric results. RESULTS: Under open oval window conditions, bone conduction hearing was found to be improved between 500 and 2000 Hz, but not at 4000 Hz. After insertion of the prosthesis, an additional improvement was evident at 500 and 1000 Hz, but a loss was seen at 2000 and 4000 Hz. CONCLUSION: This is the first investigation reported in which audiometry was performed under open oval window conditions during stapes surgery. Our results demonstrate that at least part of the preoperative bone conduction hearing loss in otosclerosis must be of mechanical, but not of sensorineural origin, as already suspected by Carhart. The fixed footplate suppresses cochlear micromechanics mainly at frequencies between 500 to 2000 Hz. Furthermore, the loss in bone conduction hearing at 2000 and 4000 Hz after insertion of the prosthesis indicates that rather than the surgical procedure of total removal of the footplate, other factors such as the handling of the prosthesis or its mechanical properties after insertion cause high-frequency hearing loss after stapes surgery.

Electric-acoustic stimulation of the auditory system: a review of the first decade.

Electric-acoustic stimulation (EAS) was developed for individuals with a profound hearing loss in the high frequencies and a substantial residual low-frequency hearing (LFH). For this group of candidates, conventional hearing aids often neither provided sufficient amplification nor were they considered suitable for cochlear implantation due to the possible destruction of residual hearing capabilities. With EAS, combining electric stimulation with an ipsilateral acoustic stimulation, preservation of residual LFH and the development of a new speech processor uniting both strategies became essential. Over the last years, EAS has developed further and advanced in electrode design and surgery techniques. This paper summarizes the history of EAS and acknowledges the tremendous work of the many research groups who contributed to the success of EAS.

Protection of inner ear function after cochlear implantation: compound action potential measurements after local application of glucocorticoids in the guinea pig cochlea.

BACKGROUND: Cochlear implant users with residual hearing often benefit greatly from simultaneous electric and acoustic stimulation. However, implantation can cause trauma to the inner ear, resulting in poorer hearing postoperatively. We investigated whether a single local injection of glucocorticoids can reduce hearing loss in long-term implanted guinea pigs. METHODS: Three groups of animals underwent bilateral surgery. One ear was implanted with an electrode, and the contralateral ear received a cochleostomy only. A single dose of the glucocorticoids triamcinolone or dexamethasone, or of artificial perilymph was infused into cochleae via cochleostomy. Compound action potentials were measured before and after application and for 3 months postoperatively. Tissue growth was measured as the percentage of the total area of the scala tympani that was obliterated. RESULTS: Ears subjected to cochleostomy only and treated with glucocorticoids demonstrated a mild hearing loss. In the implanted ears, both glucocorticoids preserved hearing at least temporarily. The volume of tissue growth within the scala tympani was not reduced, and there was no relation between the amount of tissue and hearing loss. CONCLUSIONS: Both glucocorticoids show a potential benefit for hearing preservation in implanted ears. Glucocorticoid therapy may be useful to protect residual hearing during cochlear implantation.

Assessment of the subjective benefit of electric acoustic stimulation with the abbreviated profile of hearing aid benefit.

CONCLUSION: This study demonstrates that electric-acoustic stimulation (EAS) significantly decreases the subjective impairment in speech perception. OBJECTIVES: To assess the subjective benefit of EAS over the first 12 months after EAS fitting using the Abbreviated Profile of Hearing Aid Benefit (APHAB). METHOD: Twenty-three EAS users, implanted with either the PULSAR(CI)(100) FLEX(EAS) provided with the DUET EAS processor or the COMBI40+ Medium provided with the TEMPO+ speech processor, were included. Electric stimulation was activated about 1 month postoperatively; ipsilateral acoustic stimulation was added 2 months thereafter. EAS benefit was measured preoperatively with only a hearing aid and postoperatively at EAS fitting and then 3, 6 and 12 months after EAS fitting using the APHAB. RESULTS: Subjects reported significant improvements in the global score with a mean decrease in impairment from 74% preoperatively to 45% after 3 months of EAS use. Furthermore, clinical relevance was demonstrated in multiple subscales between preoperative and first fitting reflecting a true benefit of EAS with a probability of 95%.

Testing the diagnostic value of electrical ear canal stimulation in cochlear implant candidates by functional magnetic resonance imaging.

Prior to cochlear implant (CI) surgery in children, the integrity of the auditory pathway is sometimes assessed by electrical ear canal stimulation (ECS). However, the evaluation of reactions as auditory is subjective. To test the prognostic value of ECS, functional magnetic resonance imaging (fMRI) was performed during ECS vicariously in 18 adult CI candidates. Activation of the primary auditory cortex was detected in 9 of 16 cases when auditory sensations during ECS occurred, and tended to be more bilaterally distributed in CI candidates than in normal-hearing controls. ECS sensations only tended to correlate with fMRI activations. However, solely frequency discrimination during electrical stimulation predicted CI outcome, but neither other auditory sensations nor fMRI activations did so satisfactorily, which limits the diagnostic value of these measures. Instead, preoperative residual hearing (nonamplified and amplified) was a robust predictor for CI benefit.

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.

Representation of acoustic signals in the human cochlea in presence of a cochlear implant electrode.

BACKGROUND: In subjects with remaining low frequency hearing, combined electric-acoustic stimulation (EAS) of the auditory system is a new therapeutic perspective. Intracochlear introduction of a cochlear implant electrode, however, may alter the biomechanical properties of the inner ear and thus affect perception of acoustic stimuli. STUDY DESIGN: Based on histological observations of morphologic changes after cochlear implantation in cadaveric and post mortem studies the effects of basilar membrane (BM) stiffening in the ascending basal and middle turns of the cochlea due to close contact of the BM with the electrode were simulated in a 3D-computational finite element model of the inner ear. To verify our simulated results, pre- and postoperative pure-tone audiograms of 13 subjects with substantial residual hearing, who underwent cochlear implantation, were evaluated. RESULTS: In the scenario of partial BM-fixation, acoustic energy of middle (2 kHz) and high (6 kHz) frequency was focused basally and apically to the fixed section, increasing BM displacement amplitudes up to 6 dB at a stimulation level of 94 dB (SPL). Lower frequencies were not affected by fixation in the basal and middle turn of the cochlea. In implanted subjects, a small but significant decrease of thresholds was observed at 1.5 kHz, a place in tonotopy adjacent to the tip region of the implanted electrode. CONCLUSION: Our model suggests that stiffening of the basilar membrane adjacent to an implanted electrode into the basal and middle cochlear turn did not affect BM movement in the low frequency area. Focussing of acoustic energy may increase perception in regions adjacent to the fixed section. Observations in implanted subjects were concordant with our model predictions. High frequencies, however, should not be amplified in patients using EAS to avoid disturbances in discrimination due to tonotopically incorrect frequency representation.

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.

The large vestibular aqueduct--case report and review of the literature.

Patients with a large vestibular aqueduct (LVA) suffer from a loss of hearing in childhood at an early onset. An acute loss of hearing can be precipitated by minor head trauma. Until now there seems to be no sufficient therapy for stopping the progression of a loss of hearing. It has been shown that a cochlear implantation is a worthwhile procedure if the patient is almost deaf. We report the case of a patient with a bilateral LVA. A loss of hearing was confirmed at the age of 16 months. Exposure to loud noise triggered an acute progression of the hearing loss. At the age of 18 years, LVA was confirmed radiologically, revealing an enlarged endolymphatic duct and sac in MRI scans and an enlarged vestibular aqueduct in the CT scan. We successfully performed a cochlear implant (MED-EL, Combi 40+ flex). Proceeding from this case report, the paper reviews the literature on LVA.

Combining perimodiolar electrode placement and atraumatic insertion properties in cochlear implantation -- fact or fantasy?

CONCLUSIONS: Except for basal cochlear traumatization, all specimens implanted into scala tympani showed atraumatic insertion properties and good perimodiolar electrode positioning. Cochleostomy preparation and placement can have a significant impact on levels of basal cochlear trauma. OBJECTIVE: In the past, perimodiolar cochlear implant electrodes increased the risk for intracochlear traumatization when compared to free-fitting arrays. Recently, however, clinical evidence for atraumatic perimodiolar implantations with preservation of residual hearing has been described. The aim of this paper was to histologically evaluate a perimodiolar cochlear implant array for its insertion properties in cadaver human temporal bones. Surgical and electrode factors, as well as preparation artifacts influencing intracochlear trauma, were considered in the evaluation. MATERIALS AND METHODS: Sixteen human temporal bones were harvested up to 24 hours post mortem and implanted immediately with the Nucleus 24 Contour Advance cochlear implant electrode array. Implantations were either performed using a regular caudal approach cochleostomy or through the round window membrane. After implantation, all bones underwent special histological processing, which allowed sectioning of undecalcified bone. Insertion properties were evaluated according to a grading system. RESULTS: Fourteen specimens were implanted into scala tympani and only two exhibited basal trauma attributable to electrode insertion characteristics. Two bones were implanted into scala vestibuli after causing trauma in the region of the cochleostomy. Insertion depths ranged from 180 degrees to 400 degrees. All bones showed good perimodiolar electrode positioning. Basal trauma due to surgical issues and histological artifacts was present in 10 of 16 bones.

Effects of a dexamethasone-releasing implant on cochleae: A functional, morphological and pharmacokinetic study.

AIM: This study evaluated the impact of a dexamethasone-releasing silicone implant on hearing function preservation, cochlear morphology and perilymph pharmacokinetics after cochlear implantation. METHODS: Guinea pigs were implanted unilaterally with silicone rods containing either 2% dexamethasone (DEXA group, n = 18) or no dexamethasone (control group, n = 17). Auditory brainstem response (ABR) and distortion product otoacoustic emissions (DPOAEs) were measured preoperatively and over 6 months postoperatively. Cochlear histology using standard hematoxylin and eosin (H&E) staining and tumor necrosis factor (TNF)-alpha staining was performed 1 month postoperatively. Twenty-two guinea pigs were involved in the pharmacokinetic study, and real-time drug concentrations in perilymph were investigated using high-performance liquid chromatography (HPLC). The Mann-Whitney U test (1-tailed) was used for statistical analyses. RESULTS: ABR and DPOAE testing demonstrated decreased hearing function immediately postoperatively followed by a progressive hearing loss within the first day postoperatively. There was almost no observable hearing improvement in the control group from 1 week to 6 months postoperatively, but hearing levels in the DEXA group improved gradually from 1 week to 12 weeks. Hearing loss in the DEXA and control group was 5.0 ± 3.4 dB and 21.7 ± 5.3 dB, respectively at a 16-kHz stimulus frequency 6 months postoperatively. The difference in threshold shifts was present throughout all measured frequencies, and it was significant at 4-24 kHz. The morphological study revealed new fibrosis formation in the scala tympani, which encapsulated the implanted electrode. TNF-alpha positive staining in the cochleae of the DEXA group was less evident than the control group. The pharmacokinetic study revealed a peak perilymph concentration 30 min postoperatively and sustained dexamethasone release at least 1 week postoperatively. CONCLUSION: Cochlear implants that incorporate dexamethasone can release drug chronically in the inner ear and induce significant long-term recovery and preservation of auditory function after implantation.

Development and evaluation of an improved cochlear implant electrode design for electric acoustic stimulation.

OBJECTIVE: The objective of this study was to assess the intracochlear position and the extent of trauma to cochlear structures using a new prototype electrode carrier (Flex EAS). Special emphasis was placed on the practicality for combined electric and acoustic stimulation of the auditory system. STUDY DESIGN: Human temporal bones were evaluated histologically after insertion of the electrodes, and insertion forces were measured in an acrylic model of the scala tympani. METHODS: 1) Insertion forces with the regular C40+ array and the new electrode prototype were measured in an acrylic model of the scala tympani. 2) Ten human temporal bones were implanted using the same surgical procedure as in vivo. All bones underwent fixation methylmethacrylate embedding to allow cutting of the undecalcified bone with the electrode in situ. In addition, radiography of the implanted devices was performed and correlated to histologic results. Electrode positions and trauma to cochlear structures were then evaluated histologically. RESULTS: All insertions of the new electrode array were performed in the scala tympani of the cochlea. All insertions were atraumatic and covered one cochlear turn. The only effect on cochlear structures that could be observed was a slight lifting of the basilar membrane in the middle turn limited to the tip of the electrode. In three bones, basal trauma, which resulted from the cochleostomy itself, could be observed as well. All neural structures remained intact. CONCLUSIONS: The new electrode prototype provides very good mechanical properties for safe and atraumatic implantation. All criteria for the use in hearing-preservation cochlear implantation for electric and acoustic stimulation were fulfilled. Surgical measures to prevent basal trauma appear to be very important.

Application of carbon dioxide and erbium:yttrium-aluminum-garnet lasers in inner ear surgery: an experimental study.

BACKGROUND: Surgery of the inner ear requires atraumatic techniques to preserve the sensory structures of the inner ear. With modern laser technology, surgery can be performed without mechanical contact, reducing the risk of direct mechanical trauma. However, energy transfer by laser light has the potential to induce damage by heating, pressure waves, or direct irradiation, depending on the properties of the laser and parameters of application. HYPOTHESIS: The application of laser systems in inner ear surgery may have an advantage over traditional techniques; the carbon dioxide laser in continuous mode with an automated scanning procedure and the erbium:yttrium-aluminum-garnet laser were compared with a mechanical technique, using a diamond drill. METHODS: A cochleostomy in the basal cochlear turn of guinea pigs was created. Thresholds in response to frequency-specific stimuli and clicks were established by recording compound action potentials, both before and after the procedure. RESULTS: The best results in terms of preservation of cochlear function were obtained with the diamond drill. However, a single ear had a complete loss after fracture of the cochlear wall. Mean threshold shifts observed with the carbon dioxide laser were slightly greater, showing mild high-frequency losses, although differences to the group of drilling were not statistically significant. Results with the erbium:yttrium-aluminum-garnet laser showed significantly higher degrees of hearing loss than the other two groups, predominantly in the high-frequency region. CONCLUSIONS: Mechanical opening of the inner ear using a microdrill can be performed with minimal hearing loss; however, it carries the risk of direct trauma to the inner ear. The carbon dioxide laser with a new scanning technology as a noncontact procedure is shown to be effective and safe. It can be regarded as a useful tool in inner ear surgery. The erbium:yttrium-aluminum-garnet laser has a greater potential to cause damage.

Cochlear implantation via the round window membrane minimizes trauma to cochlear structures: a histologically controlled insertion study.

OBJECTIVE: To evaluate cochlear implant trauma to intracochlear structures when inserting the electrode via the round window membrane. MATERIAL AND METHODS: Eight fresh human temporal bones were evaluated histologically after insertion using two types of cochlear implant array. Bones underwent a special fixation and embedding procedure that allowed sectioning of undecalcified bone with the electrode in situ. Insertions depths were evaluated radiologically and histologically. RESULTS: All arrays were found in the scala tympani of the cochlea. Basal trauma could be avoided in all but one specimen. The mean depth of insertion was 382.5 degrees. Apically, only one implanted bone showed cochlear trauma exceeding lifting of the basilar membrane. CONCLUSION: Insertions through the round window membrane were shown to be atraumatic, even in basal cochlear regions. This route of insertion might be very effective for combined electric and acoustic stimulation of the auditory system.

Conservation of low-frequency hearing in cochlear implantation.

OBJECTIVES: As results with cochlear implants have continued to improve, patients with some remaining cochlear function have become eligible for cochlear implantation. Thus, preservation of acoustic hearing after implantation has gained importance. Hearing preservation can be considered a benchmark for atraumatic implantation preventing neural degeneration from loss of residual hair cells or subsequent to local trauma. In this prospective study, the possibility of preserving low-frequency hearing in cochlear implantation using a modified surgical technique has been explored. MATERIAL AND METHODS: In a prospective study design, 14 subjects with considerable low-frequency hearing of 20-60 dB in the frequency range 125-500 Hz but with unsatisfactory speech understanding with hearing aids of < 35% monosyllabic word understanding were implanted with a MED-EL COMBI-40+ cochlear implant. The insertion depth was intentionally limited to 19-24 mm to prevent damage to low-frequency regions of the cochlea. Pre- and postoperative pure-tone thresholds were measured. RESULTS: Hearing was conserved within 0-10 dB in 9/14 subjects and within 11-20 dB in 3/14; in 2/14 subjects hearing was completely lost in the implanted ear. Thus hearing could at least partially be conserved in 12/14 subjects (86%). Median threshold values decreased by 10, 15, 17.5 and 5 dB at 125, 250, 500 and 1000 Hz, respectively. Even high levels of hearing, e.g. 30 dB at 500 Hz, could be maintained after implantation in some subjects. CONCLUSIONS: This study reports successful conservation of hearing after cochlear implantation using a modified surgical technique. Even high levels of hearing could be maintained, showing that implantation of an intracochlear electrode can be performed atraumatically with preservation of functional structures.

Hearing preservation in cochlear implantation for electric acoustic stimulation.

OBJECTIVE: To evaluate the possibility of preservation of low-frequency hearing in atraumatic cochlear implant electrode insertion procedures for combined, ipsilateral electric and acoustic stimulation. MATERIAL AND METHODS: A total of 21 patients were implanted with a MED EL C40+ cochlear implant using an atraumatic electrode insertion technique to preserve residual low-frequency hearing. Pure-tone audiometric thresholds were measured pre- and postoperatively to evaluate the degree of preserved hearing. Speech discrimination tests in quiet and with background noise were performed in a patient with successful hearing preservation. RESULTS: Using the atraumatic electrode insertion procedure with an insertion depth of 360 degrees (18-24 mm), hearing preservation could be achieved in 18/21 patients (85.7%). Three patients (14.3%) lost their residual low-frequency hearing after the implantation. Residual hearing was preserved completely in 13 patients (61.9%) and partial hearing preservation was possible in 5 (23.8%). Preliminary speech discrimination tests showed a dramatic benefit for the combined electric and acoustic stimulation mode compared to cochlear implantation alone. CONCLUSION: Preservation of low-frequency hearing in cochlear implantation is possible in patients implanted because of profound high-frequency deafness. With the development of new, more atraumatic electrode designs, preservation of residual hearing should be further improved.

A safety evaluation of dexamethasone-releasing cochlear implants: comparative study on the risk of otogenic meningitis after implantation.

CONCLUSION: Dexamethasone released from a cochlear implant seems not to enhance the risk for postoperative infections. OBJECTIVE: Dexamethasone has a positive impact on hearing preservation for electric acoustic stimulation (EAS). Due to their antiproliferative and immunosuppressive properties, steroids may enhance the risk of postoperative infections. A comparative study was performed to evaluate the risk of pneumococcal meningitis after implantation of dexamethasone-eluting cochlear implants. METHODS: Thirty guinea pigs were implanted with non-eluting (n = 15) or dexamethasone-eluting (n = 15) cochlear implant electrode dummies. After 5 weeks, animals were exposed to a virulent strain of Streptococcus pneumoniae. The two groups were compared based on the meningitis rate. Animals were observed for 5 days for signs of meningitis. Meningitis was verified by clinical outcome as well as by pleocytosis and presence of bacteria in cerebrospinal fluid. Results were confirmed by histological examination of brains and cochleae, clinical findings and culture. RESULTS: There was no significant difference in meningitis risk between the two groups. In the group with non-eluting implants, 3 of 15 animals developed meningitis, while in the group with dexamethasone-eluting implants 4 of 15 showed signs of meningitis. In this study dexamethasone-releasing implants did not significantly increase the risk of postoperative pneumococcal otogenic meningitis.

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.

Combined aesthetic and functional reconstruction of ear malformations.

BACKGROUND: Surgery for major malformations of the outer and middle ear involves aesthetic as well as functional aspects. Whereas reconstruction of the auricle with autogenous rib cartilage is well established and has shown favorable results, functional repair using classic reconstructive techniques is possible only in a limited group of patients and the outcome is often unsatisfactory. Active middle ear implants (MEI) offer a promising alternative to reconstructive surgery. METHOD: Fifteen patients with ear malformations underwent implantation of an active middle ear implant (Soundbridge), with or without concomitant reconstruction of the auricle. The vibrating element, the floating mass transducer (FMT), was coupled either to the round window, stapes, oval window or incus, according to each individual's anatomical middle ear situation. Aesthetic as well as functional outcomes were evaluated. RESULTS: Implantation could be integrated into aesthetic reconstruction of the auricle without complications. In 14/15 patients, a satisfactory functional result could be achieved (< 30 dB pure-tone audiometry). Neither facial nerve palsy nor inner ear hearing loss was observed after implantation. CONCLUSION: The versatile form of the FMT of the Soundbridge allows for adaptation of the coupling procedure to the individual anatomical situations. Implantation of a Soundbridge MEI is a valuable option for functional reconstruction of the malformed ear, which may offer more consistent and reliable results than classic reconstructive surgery.