Jean-Pierre Lavieille

A middle ear implant, the symphonix Vibrant soundbridge: Retrospective study of the first 125 patients implanted in France

Objective The Vibrant Soundbridge is an active semi-implantable middle ear implant for the rehabilitation of patients with a sensorineural hearing loss who are not able to derive adequate benefit from conventional hearing aids. A retrospective study was performed to assess the overall level of satisfaction of implanted patients and to investigate the potential determinants of postoperative success. Study Design A retrospective survey of audiological data from repeated measures and subjective data from self-assessment scales administered postoperatively was conducted to determine the degree of benefit and satisfaction for Vibrant Soundbridge implantees. Setting Twenty-one tertiary referral and teaching hospitals. Subjects The first 125 VSB implantees implanted in France between August 1997 and May 2001 were included in the study. Results No clinically significant change was observed for residual hearing postoperatively. Most patients (83%) reported they were either satisfied or very satisfied with the Vibrant Soundbridge. Analysis of correlation revealed a moderate correlation (Pearson coefficient r = 0.59) between the degree of benefit reported via the patient survey and the degree of benefit reported via the Glasgow Benefit Inventory. A moderate correlation (Pearson coefficient r = 0.66) was observed between speech comprehension scores in quiet for the preoperative unaided condition and the postoperative aided Vibrant Soundbridge condition. No correlation was observed between subjective reports of satisfaction postoperatively and performance on preoperative objective tests or patient characteristics. Conclusion The results indicate a high level of satisfaction with the VSB as a treatment of sensorineural hearing impairment in patients with a wide range of characteristics. Preoperative scores for unaided speech comprehension tests in quiet may be a potential indicator of success on aided Vibrant Soundbridge speech comprehension tests postoperatively but do not reflect patient satisfaction with the device reported on self-assessment scales.

A Multicenter Study of the Vibrant Soundbridge Middle Ear Implant: Early Clinical Results and Experience

Objective The Vibrant Soundbridge (VBS; Symphonix Devices, Inc., San Jose, CA, U.S.A.) is an active, semi-implantable, middle ear hearing device that directly drives the ossicular chain and is used in the treatment of patients with mild to severe sensorineural hearing loss. The benefits of the VBS and the effects of surgery were examined and compared with the preoperative aided condition in 25 patients with implants. Study Design Single-subject repeated-measures evaluations were performed with each patient acting as his or her own control. Objective audiologic measures and subjective questionnaires also were used. Setting Five tertiary referral and teaching hospitals. Subjects Adult patients had bilateral sensorineural hearing loss (average hearing loss, 56 dB; range, 33–80 dB). Twenty-one patients had worn a conventional hearing aid before surgery (11 binaurally, 10 monaurally). Four patients had not used a conventional hearing aid before surgery. Intervention Rehabilitative. Results No significant change in residual hearing after surgery was observed. Functional gain was significantly superior with the VBS. No significant differences were observed for aided speech recognition in quiet. A significant improvement in communication in various listening conditions was reported with the VBS as compared with conventional hearing aids. Conclusion The VBS surgical implantation procedure does not affect the residual hearing level in the implanted ear, nor does it present any unacceptable risk. Measurable benefit from the VBS in comparison with conventional amplification was demonstrated with regard to the provision of superior usable amplification and greater ease in communication in daily listening environments for the majority of patients.

European results with totally implantable carina placed on the round window: 2-year follow-up.

Objectives: First, to assess for the performance of the Carina placed on the round window at various European centers; second, to study the follow-up after 2 years and discuss limitations and technical issues; and finally, to further develop our understanding of the principles of acoustic transfer through the round window. Materials and Methods: Eleven patients were included in this retrospective study (7 women and 4 men) from 7 European tertiary referral hospitals (4 centers in France, 2 in Belgium, 1 in Spain). The mean age was 50.8 years (35-71 yr). All patients have multiple previous surgeries (>3 surgical procedures) for otosclerosis (3 patients) or chronic otitis media (8 patients), and in all cases, the stapes was not accessible due to obliteration by sclerotic tissue. Preoperative and postoperative air conduction, bone conduction, as well as aided and unaided thresholds and speech scores were measured. Results: No significant differences were observed between preoperative and postoperative air-conduction and bone-conduction pure-tone averages. The average free field functional gain obtained with the implant ranged from 22 to 42 dB at each individual frequency, with a mean of 29 ± 5 dB across all audiometric frequencies. Word recognition scores demonstrated significant differences between unaided and implant-aided conditions. Complications included 2 cases of postoperative infection (including 1 anacusis) that required explantation, and 1 case reduced initial benefit, followed by a nonfunctioning device. In 10 patients, postoperative hearing was unchanged. The 8 other patients are using their implant daily. Conclusion: These results show that this option is valid for patients with a fixed footplate and unsuccessful previous surgeries or patients who cannot benefit from a stapedotomy for anatomic reasons. In some cases, access to the round window membrane could represent a limitation. However, these promising initial results establish the need for further works with regard to 3 issues: 1) clinical data studies are needed, including a greater number of patients to confirm these preliminary results; 2) a long-term follow-up must be performed to detect any possible cochlear adverse effects, in particular, on the basilar membrane; 3) the effect of fascia interposition and tip size has to be evaluated in experimental studies.

Squamous cell carcinoma of the temporal bone: results and management.

Objective: Evaluation of the management and survival of patients treated for temporal bone squamous cell carcinoma. Study Design: A retrospective analysis. Setting: Tertiary care, academic referral center. Patients: Twenty-eight patients underwent primary treatment for squamous cell carcinoma of the temporal bone. Interventions: The patients were staged using the modified Pittsburgh staging system. Patients underwent a local resection, lateral temporal bone resection, or a subtotal lateral temporal bone resection usually followed by radiotherapy. Main Outcome Measure: The survival rate of patients grouped by tumor size was calculated. Results: Staging revealed 12 pT1, 2 pT2, 4 pT3, and 10 pT4 tumors. The mean follow-up was 34 months (2-132 mo). The Kaplan-Meier survival curves showed survival rates at 5 years of 83 and 25% for the stages pT1 and pT4, respectively. The pooled survival curves showed survival rates at 5 years of 85 and 46% for the stages pT1p/T2 and pT3/pT4, respectively. Conclusion: Long-term prognosis of the carcinoma of the external auditory canal mainly depends on the stage and primary treatment. Surgery may consist of a lateral temporal bone or subtotal temporal bone resection; in T3 and T4 tumors, resection may be combined with a superficial parotidectomy. If disease is diagnosed in the neck or parotid, then a neck dissection and total parotidectomy may also be performed. Additional radiotherapy should be provided in incompletely resected T1 and all T2 and T3 tumors and part of the T4 tumors. T4 tumors may be treated according to their subclassification based on the anatomic extension.

Intraoperative auditory monitoring in vestibular schwannoma surgery: new trends

Objective To investigate the efficiency of a new method of brainstem auditory-evoked potential (BAEP) monitoring during complete vestibular schwannoma (VS) resection with attempted hearing preservation. Material and Methods Dedicated software providing near real-time recording was developed using a rejection strategy of artifacts based on spectral analysis. A small sample number (maximum 200) is required and results are obtained within 10 s. Fourteen consecutive patients with hearing class A operated on for VS, in an attempt to preserve hearing, participated in the investigation. Postoperatively, 7 patients (50%) had useful hearing (hearing class A, 4/14; hearing class B, 3/14) on the operated side. Seven patients (50%) were reduced to hearing class D. Results Drilling of the internal auditory canal (IAC) and tumor removal at the lateral end of the IAC were identified as the two most critical steps for achieving hearing preservation. Intraoperative BAEP monitoring was sensitive in detecting auditory damage with useful feedback but its effectiveness in preventing irreversible hearing impairment was not demonstrated in this study. Conclusions Combined BAEP and direct auditory nerve monitoring using the same equipment will be performed in the future in an attempt to enhance the chances of preventing irreversible hearing damage, and possibly to improve the hearing outcome significantly.

Rehabilitation of canal wall down mastoidectomy using a titanium ear canal implant.

Objective: To describe the rehabilitation of canal wall down mastoidectomy cavities using a custom-made titanium wall implant and to analyze the benefits and the long-term functional results. Study Design: Retrospective analysis. Setting: Tertiary care center. Patients and Methods: We have reviewed the data of 113 consecutive operated ears from 106 patients during a 9-year period (1993-2002). The following preoperative and postoperative criteria were compared: the persistence or resolution of otorrhea, cholesteatoma, and vertigo; external auditory canal healing, position of the titanium prosthesis, and tympanic membrane findings. In addition, the hearing status was evaluated by comparing the preoperative data with the 6-month and last follow-up postoperative data to deduce the air-bone gap (ABG) and the auditory gains. Results: Operated ears (88.5%) were dry after the initial rehabilitation, and 97.3% were dry after a revision surgery for defective canal healing. Most patients (96.5%) were free of vertigo. The external auditory canal wall was in a good position in all cases and allowed for a primary skin healing process in 84% of cases; the remaining patients underwent revision surgery under local anesthesia to complete the healing. The reconstructed drum was stable and anatomic in 73% of the cases (n = 83) after the first surgery. Thirty-six patients (32%) underwent various revision procedures: aeration tube placement for 16 patients with mesotympanic retraction and/or serous effusion, revision surgery for 12 patients with attic retraction or evidence of cholesteatoma, and revision for 5 patients with perforation. At last follow-up, 100% of the ear canals were healed, and 85% of patients had a normal tympanic membrane. No residual cholesteatoma was found at last follow-up. Thirty-six percent of patients had an ABG within 20 dB at last follow-up, and 69% within 30 dB. Conclusion: The rehabilitation of canal wall down mastoidectomies improves the quality of life of patients regarding cholesteatoma recurrence, otorrhea, and vertigo in more than 95% of cases and stabilizes the hearing loss to less than 30 dB of ABG for more than two thirds of patients. The main unresolved problem is the persistent dysfunction of the middle ear cavity, with unsatisfactory auditory improvements. Middle ear implants represent in selected cases a new solution to rehabilitate the refractory hearing losses.

Bilateral vibrant soundbridge implantation: audiologic and subjective benefits in quiet and noisy environments.

Abstract Conclusions. The results support bilateral sequential implantation for patients who are not completely satisfied after implantation of one side. Objective. To evaluate the benefit of bilateral Vibrant Soundbridge middle ear implantation as compared with unilateral implantation in quiet and noisy environments. Methods. This was a multicentric and retrospective study of 15 patients with symmetrical sensorineural hearing loss who were implanted sequentially in both ears. The performance of each subject was compared under three conditions: with the right implant activated, with the left implant activated, and with both implants activated. Audiometric tests were compared with self-assessment subjective evaluation by questionnaire. Results. Both qualitative and quantitative assessments demonstrated improvement in speech intelligibility, especially in background noise, but also for low voice intensity in quiet.

Vein versus tragal perichondrium in stapedotomy.

Objective: To assess, in otosclerosis surgery, whether the vein or the tragal perichondrium in stapedotomy with interposition yields the better long-term hearing outcome. Study Design: A retrospective chart review of prospectively collected audiometric data of 452 ears. Setting: Academic tertiary otology-neurotology referral center. Patients: Four hundred fifty-two stapedotomies with interposition were performed in 412 patients (bilateral in 40 patients) by the senior author (R.C.) between 1987 and 1998. A tragal perichondrium graft was used in 314 cases and a vein graft was used in 138 cases as sealing material of the oval window. Main Outcome Measures: Audiometric data were recorded at 4 months, at 1 year, and at 3 years after surgery after American Academy of Otolaryngology–Head and Neck Surgery guidelines, except for thresholds at 3 kHz, which were not available and which were replaced with those at 4 kHz. Results: There were no significant intergroup differences in initial or late postoperative hearing outcome with regard to change in the pure-tone average bone conduction and air-bone gaps, or sensorineural hearing loss. Ears treated with a vein graft showed statistically better postoperative 2-kHz air-bone gap closure (p = 0.0157), but the pure-tone average air-bone gap difference was not significant. Postoperative air-bone gap closure to within 10 dB was achieved in 91% of cases in the vein group and in 76% of cases in the perichondrium group. Specific study of the bone conduction level at 4 kHz showed a sensorineural hearing loss greater than 10 dB in 8% of cases in the vein group and in 11% of cases in the perichondrium group. One case of complete sensorineural hearing loss was observed with a tragal perichondrium graft (0.22%). Conclusion: These results suggest that the vein should be preferred to the tragal perichondrium in stapedotomy with interposition.

A middle ear implant with a titanium canal wall prosthesis for a case of an open mastoid cavity

OBJECTIVE Open mastoid cavity rehabilitation should focus on both anatomical and functional aspects. We hereby report the technique and results of a combined strategy to reconstruct the external ear canal using a titanium wall implant and the middle ear using a fully implantable active middle ear device. METHODS A fully implantable active middle ear implant was used to rehabilitate the mixed hearing loss of a 63-year-old woman, and a titanium posterior canal wall prosthesis was used to reconstruct the external ear canal during the same procedure. The middle ear implant was placed directly on the footplate. The auditory results were compared to the preoperative unaided thresholds and to the amplification of a conventional hearing aid. RESULTS Following the procedure, there was an anatomically normal external ear canal with a healed tympanic membrane separating the external from the middle ear spaces. The postoperative auditory gains were on average 31.8 dB on pure-tone audiometry, and 20 dB on speech reception threshold. No complications occurred. CONCLUSION The rehabilitation of the external ear canal in an open mastoid cavity allows for clinical follow-up of the patient, and the implantation of an active middle ear implant provides appropriate auditory gains both in pure tones and in speech reception thresholds.

Surgical management of lesions of the internal carotid artery using a modified Fisch type A infratemporal approach.

Objective: To report seven cases of vascular repair of the internal carotid artery (ICA) using a modified Fisch type A infratemporal approach and a venous grafting. Study Design: Retrospective case review. Setting: Tertiary care center. Patients: We have analyzed the clinical presentation, paraclinical assessment, and postoperative results regarding the vascular repair and the facial and auditory function from seven consecutive patients. All patients have been operated on by a multidisciplinary team of ENT and vascular surgeons. Results: The study includes four men and three women, aged from 21 to 62 years old. Six patients suffered from vascular traumatic injury after motor vehicle accident (n = 5) or cervical manipulation (n = 1) and one patient presented an atheromatous stenosis. All benefited from a vascular repair with a venous grafting through a modified Fisch Type A infratemporal approach. No death and no new stroke were noted (mean follow-up, 34 mo). The postoperative angiographies showed six functional grafts and one asymptomatic thrombosis. Six immediate postoperative facial palsy occurred but recovered to Grade I or II within 6 months. There was one traumatic injury of the facial nerve and one postoperative anacusis. For the six other patients, the reconstitution of the external auditory canal and ossicular chain allowed to limit the hearing loss to a mean air-bone gap of 22.5 dB (range, 15-35 dB). Conclusion: The lesions of the intrapetrous aspects of the ICA remain the subject of debates regarding the indication for a vascular repair. For young or in good health patients, the infratemporal approach provides a safe and reliable access to the horizontal segment of the ICA, offering to the vascular surgeons optimal conditions for the vascular repair.