Safety and effectiveness of the Bonebridge transcutaneous active direct-drive bone-conduction hearing implant at 1-year device use.

The objective of this study is to evaluate the safety and efficacy of a new transcutaneous bone-conduction implant (BCI BB) in patients with conductive and mixed hearing loss or with single-sided deafness (SSD), 1 year after surgical implantation. The study design is multicentric prospective, intra-subject measurements. Each subject is his/her own control. The setting is nine university hospitals: 7 French and 2 Belgian. Sixteen subjects with conductive or mixed hearing loss with bone-conduction hearing thresholds under the upper limit of 45 dB HL for each frequency from 500 to 4000 Hz, and 12 subjects with SSD (contralateral hearing within normal range) were enrolled in the study. All subjects were older than 18 years. The intervention is rehabilitative. The main outcome measure is the evaluation of skin safety, audiological measurements, benefit, and satisfaction questionnaires with a 1-year follow up. Skin safety was rated as good or very good. For the mixed or conductive hearing loss groups, the average functional gain (at 500 Hz, 1, 2, 4 kHz) was 26.1 dB HL (SD 13.7), and mean percentage of speech recognition in quiet at 65 dB was 95 % (vs 74 % unaided). In 5/6 SSD subjects, values of SRT in noise were lower with BB. Questionnaires revealed patient benefit and satisfaction. The transcutaneous BCI is very well tolerated at 1-year follow up, improves audiometric thresholds and intelligibility for speech in quiet and noise, and gives satisfaction to both patients with mixed and conductive hearing loss and patients with SSD.

Platelet-rich fibrin (PRF): an autologous packing material for middle ear microsurgery.

OBJECTIVES: To assess the use of PRF prepared using an optimised protocol in middle ear surgery as a substitute for conventional packing products of animal origin such as collagen derived from porcine skin. METHODOLOGY: A retrospective study of 108 patients in whom optimised PRF was used exclusively to pack the external auditory canal or middle ear. The effectiveness or harmlessness of the PRF was evaluated by assessing a range of parameters. A morphological comparison was also made of PRF produced using the Choukroun procedure and our procedure. RESULTS: The success rate of the repair of the tympanic membrane one year after the surgery was 45/48 patients. In 5 of 63 patients in whom a retro-auricular approach and wall-up technique were used, granuloma was observed along the incision in the ear canal. Granuloma was not seen in any of the 23 patients undergoing a procedure with an endaural approach. CONCLUSION: The use of a material prepared from patients themselves and not of animal origin has numerous advantages in terms of biocompatibility and safety, without any adverse effect on the success rate for general middle ear procedures. The protocol is simple and does not prolong the time spent by the patient in the operating theatre. The Choukroun technique should be modified to prevent excessive failure rates in PRF processing.

Prevalence and spectrum of SDHx mutations in pheochromocytoma and paraganglioma in patients from Belgium: an update.

Since the early 2000s, the prevalence and spectrum of mutations in genes encoding subunits of succinate dehydrogenase (SDHx) were reported in large cohorts of patients with pheochromocytoma (PC) and paraganglioma (PGL) from most Western countries. Unfortunately, in Belgium, no equivalent work was performed thus far. Therefore, the aim of the work was to look for mutations in SDHx genes and genotype-phenotype correlations in patients with PC and/or PGL from Belgium. Screening of the coding parts of SDHx genes and deletion search were performed in all patients with PC and/or PGL referred to the -Cliniques Universitaires Saint-Luc from 05/2003 to 05/2011. Genetic screening was performed in 59 unrelated head and neck (hn)PGLs (8 fami-lial) and 53 PCs (7 extra-adrenal; 3 metastatic). In hnPGLs, 10 different SDHD mutations (3 substitutions, 5 deletions, 2 splice site mutations) were detected in 16 patients, including 7 familial cases and 9 apparently sporadic cases. In the same subset, we found 8 different SDHB mutations (5 substitutions, 1 splice site mutation, 1 deletion, 1 duplication) in 10 patients with sporadic hnPGL without evidence of malignancy. No SDHx mutation was detected in patients harboring PCs and no SDHC mutation whatsoever. In conclusion, in our multicentric database of PC-PGLs from Belgium, (i) the prevalence of SDHx mutations was high in hnPGLs (44% in the whole subset, 37% of apparently sporadic cases); (ii) in sporadic cases, the prevalence of SDHB mutations was high (20%), similar to that of SDHD (18%); and (iii) no SDHx mutation was found in a subset of mostly adrenal, benign PCs.

Comparison between new and old generation RetroX auditory implants.

OBJECTIVE: To compare post aural soft tissues tolerance of the old and new titanium RetroX (Auric GmbH, Rheine, Germany) tube, and to compare the hearing improvements between the old (DSP-pro) and the new (Concertino) hearing aid units of the RetroX. METHODOLOGY: Retrospective case review of 46 patients with high-frequency sensorineural hearing loss, fitted with DSP-pro or Concertino, and who received 51 implantations (with the old or new generation titanium tube) in a tertiary referral center at a university hospital. The RetroX consists of an electronic unit situated in the postaural sulcus connected to a titanium tube implanted under the auricle between the sulcus and the external auditory meatus. Implanting requires minor surgery (10 minutes under local anaesthesia). Three months after their implantation, patients were asked to fill out a questionnaire to evaluate acoustic feedback annoyance and to undergo 3 audiometric tests: pure-tone audiometry in silence, speech audiometry in silence, and speech audiometry in noise. RESULTS: The new tube is more reliable (12 explantations from patients who received 26 older tubes compared with 1 explantation in 25 who received new tubes) even if the size must be adjusted more often (2/26 for the old model and 5/25 for the new one). Concertino allows a higher amplification before feedback appears, which improves hearing gain. CONCLUSIONS: The new RetroX is better tolerated than the older one, and improves hearing ability.

Today's indications for cochlear implantation.

Today's indications for cochlear implantation. During the last twenty years, the indications for cochlear implants (CIs) extended significantly due to positive experience with CIs, improved CI technology, and safer surgery. This paper reviews the classical and emerging indications for CIs anno 2007. Providing a postlingually deaf adult with a unilateral CI has been the earliest indication and remains the standard indication. However, CIs are also indicated for prelingually deaf adults, and for children younger than one year old. Recently, CIs are also indicated for adults with residual hearing: when best aided sentence recognition scores in quiet are lower than 70%. CIs for patients with residual hearing sometimes imply the use of a bimodal CI; a device that stimulates the cochlea both electrically and acoustically. Another promising evolution is bilateral implantation. Nowadays, it has also become possible to place a CI in the malformed cochlea. When an auditory nerve is absent or when implantation failed despite a functional device, auditory brainstem implants can restore some form of hearing to the deaf.

Rehabilitation of high-frequency hearing loss with the RetroX auditory implant.

The RetroX is a new semi-implantable hearing aid which does not occlude the external ear canal. It consists of an electronic unit that plugs into a titanium tube which is implanted under the pinna so as to connect the retroauricular sulcus with the inside lumen of the external ear canal. Implantation requires minor surgery which can be performed under local anesthesia. Moreover, a pre-implant simulator exists and allows patients to try the device before deciding on definite implantation. The RetroX auditory implant is indicated in case of high-frequency sensorineural hearing loss with a steep slope (ski-slope audiogram). We implanted 25 adults suffering from such a hearing loss, and we report their hearing measured after 2.5 to 15 months of use. Four patients developed a persistent granulomatous reaction which disappeared after explantation. Two patients complained of acoustic feedback and needed supplementary fitting. Twenty three of our 25 subjects are satisfied or even extremely satisfied with the hearing improvement provided by the RetroX; they wear the implant daily, from morning until evening. Audiometrically, we observed a statistically significant improvement of the pure-tone thresholds at 1, 2, 4 and 8 kHz. In quiet, the speech reception thresholds decreased by 10 dB SPL and in noise, speech intelligibility increased by 15% for signal-to-noise ratios between -5 dB and +5 dB. Up till now, our patients were implanted monaurally because of financial considerations and our initial inexperience with this new implant. The overall results, however, are promising and nowadays, we advise bilateral implantation for patients who tolerate the first implant. By doing so, we hope to improve hearing in noise and spatial sound perception.

Preparing public participation at the catchment level: comparison of three methodologies applied to the Hérault river basin.

Public participation in water resources management has increasingly been recommended to increase the effectiveness and the acceptability of proposed water management projects and plans. Different levels of public participation are possible depending on the governance context. This paper reports on the practical implementation of three different methodologies in the Hérault river catchment (France). The analysis of public view points, carried out using a quantitative opinion survey and focus groups, reveals important information needs which have to be fulfilled for any further consultation to be efficient. A complementary analysis of stakeholders' opinions, carried out through semi-structured interviews also highlights the need to construct a common knowledge base between stakeholders, expert and scientists. This is seen as a prerequisite to implementing more elaborated forms of participation.

The RetroX auditory implant for high-frequency hearing loss.

OBJECTIVE: The objective of this study was to analyze the subjective satisfaction and measure the hearing gain provided by the RetroX (Auric GmbH, Rheine, Germany), an auditory implant of the external ear. STUDY DESIGN: We conducted a retrospective case review. SETTING: We conducted this study at a tertiary referral center at a university hospital. SUBJECTS: We studied 10 adults with high-frequency sensori-neural hearing loss (ski-slope audiogram). INTERVENTION: The RetroX consists of an electronic unit sited in the postaural sulcus connected to a titanium tube implanted under the auricle between the sulcus and the entrance of the external auditory canal. Implanting requires only minor surgery under local anesthesia. MAIN OUTCOME MEASURES: Main outcome measures were a satisfaction questionnaire, pure-tone audiometry in quiet, speech audiometry in quiet, speech audiometry in noise, and azimuth audiometry (hearing threshold in function of sound source location within the horizontal plane at ear level). RESULTS: : Subjectively, all 10 patients are satisfied or even extremely satisfied with the hearing improvement provided by the RetroX. They wear the implant daily, from morning to evening. We observe a statistically significant improvement of pure-tone thresholds at 1, 2, and 4 kHz. In quiet, the speech reception threshold improves by 9 dB. Speech audiometry in noise shows that intelligibility improves by 26% for a signal-to-noise ratio of -5 dB, by 18% for a signal-to-noise ratio of 0 dB, and by 13% for a signal-to-noise ratio of +5 dB. Localization audiometry indicates that the skull masks sound contralateral to the implanted ear. Of the 10 patients, one had acoustic feedback and one presented with a granulomatous reaction to the foreign body that necessitated removing the implant. CONCLUSION: The RetroX auditory implant is a semi-implantable hearing aid without occlusion of the external auditory canal. It provides a new therapeutic alternative for managing high-frequency hearing loss.

[Adolescence and cochlear implant]. / Adolescence et implant cochléaire.

During adolescence, the identity is constructed and the communication changes. The cochlear implant may disturb the identity's construction. The restrictions and advantages may be misunderstood due to the communication difficulties. It is important to take time to discuss and explain the limits of this hearing aid. It must not be perceived as a miracle resolving all auditory and oral communication problems. The hearing aid is effective for motivated and informed adolescents. The outcome depends on the level of auditory experience and oral language development before implantation. It can be very positive. (full article translated in English available on www.ent-review.com).

Linking expert evaluations with public consultation to design water policy at the watershed level.

In view of the increasing demand for public participation in public affairs, the European Water Framework Directive requires public consultation when drawing up watershed management plans. Implementation of this Directive requires the development of methods for linking the scientific and technical knowledge of experts with the viewpoints expressed by local actors. The objective of this paper is to propose a public consultation method that can be used as early as the preliminary assessment of river basin characteristics, defined by the Directive, and at the scale of sub-watersheds that make up the district. A case study of a watershed in southern France illustrates this method.

Belgian experience with the Vibrant Soundbridge prosthesis.

The Belgian Experience with the Vibrant Soundbridge Prosthesis. The authors present the first results obtained with 13 patients implanted with the Vibrant Soundbridge, a semi-implantable electromagnetic hearing device. The first patient was implanted in October 1998. The results show that there were no significant modifications of the hearing thresholds after implantation. The average functional gain was 30 dB in tonal audiometry and 25.6 dB in vocal audiometry. All the patients are satisfied with the device and wear it daily.

[A simple audiometry test of speech intelligibility in background noise]. / Un test audiométrique simple pour mesurer l'intelligibilité vocale dans le bruit.

We propose a new audiometric test to assess French speakers' speech discrimination in noise. This soundfield test uses a standard cocktail-party background noise superimposed on Fournier's disyllabic word lists. The background noise is CD-recorded at constant 55 dB SPL. The discrimination score is measured at a signal-to-noise ratio of -5 dB, 0, and dB. In comparison with other audiometric tests in noise, our test requires only 5 minutes and is simple for both patient and audiologist. All patients are tested using the same standard condition, one that approaches daily life and uses a noise of moderate intensity. The result is reproducible and easy to calculate and graph. We propose this test for diagnosing in-noise speech intelligibility disorders and for assisting the process of conventional or implantable hearing-aid fitting.

Office-based CO2 laser-assisted tympanic membrane fenestration addressing otitis media with effusion.

OBJECTIVE: To use the CO2 laser-assisted tympanic membrane fenestration in office settings, under local anesthesia, as the sole treatment for patients with chronic otitis media with effusion (OME). BACKGROUND DATA: This new treatment ensures artificial ventilation of the middle ear for several weeks, and provides an intermediate solution between ordinary lancet-made tympanocentesis and transtympanic ventilation tube insertion. The operative technique is already well codified, and preliminary studies have demonstrated that tympanic membrane fenestration does not expose patients to any major hazard. METHODS: We treated 30 ears in 21 children and 29 ears in 24 adults. All patients had presented with OME persistent for more than 3 months. The laser tympanostomy was performed under local anesthesia, as an outpatient procedure, using a CO2 flash-scanning laser in conjunction with a handpiece (OTOLAM). Using a power of 12 W to 17 W, a single laser pulse usually sufficed to create a 2-mm-diameter circular perforation in the anteroinferior quadrant of the eardrum. RESULTS: The tympanic membrane fenestration allows avoiding ventilation tube insertion in 63% of children and 75% of adults. CONCLUSIONS: The CO2 laser-assisted tympanic membrane fenestration seems a valid therapeutic option addressing OME. This study should be pursued on a larger scale to define more precisely the indications of the laser tympanostomy.

Cataract with multifocal AMO ARRAY implants.

We have conducted a retrospective study on three hundred cataract surgeries over one year with insertion of the AMO ARRAY multifocal implant dominant for far vision. Under condition of presurgical selection and postsurgery emmetropia, 80% of patients gains multifocality without glasses.

Laser-assisted myringotomy combined with adenoidectomy in children: preliminary results.

Adenoidectomy and CO2 laser-assisted myringotomy were performed on 26 children (52 ears) diagnosed with adenoid hypertrophy and chronic otitis media with effusion. The age ranged between 2-15. The CO2 laser and a micromanipulator were adapted on the operating microscope. Repeated pulses of focused laser beam were fired in a roselike fashion in order to create a 2-mm round perforation in the antero-inferior quadrant of the eardrum. Three months after surgery, the tympanic membrane was perfectly healed. There were two cases of recurrence of middle ear fluid. There was no adverse effect and hearing results were good. We discuss the significance of these preliminary results and emphasize the need for further research.

[Lasers used by a young surgeon for stapes surgery]. / Le laser utilisé par un jeune opérateur pour la chirurgie de l'otospongiose.

We report the results of the first 38 stapes operations performed by a young surgeon. He achieved a perfect closure of the air-one gap (within 10 dB) in 89% of the patients operated on with the laser, compared with 65% of the patients operated on without laser. We discuss the significance of this difference, taking into account the multiple factors influencing the results. In our opinion, the laser helps a young surgeon to accelerate his learning curve in stapes surgery.