Emmanuel A M Mylanus

Radboud University Medical Centre (Radboudumc), Nymegen, Gelderland, Netherlands

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Publications (121)150.91 Total impact

  • [Show abstract] [Hide abstract]
    ABSTRACT: Objective: To create a system for the uniform registration and classification of complications and failures in cochlear implant surgery, and apply it to all the patients who underwent implantation in our clinic. Method: The definition of a medical complication was established, and data for all cochlear implantations performed between 1987 and 2012 were entered into a custom-made database system. Results: One or more medical complications were registered in 19.0 per cent of 1003 cochlear implantations. The incidence of 'hard failure' was 2.3 per cent. Findings revealed a decrease in device failures over the years; the rate of medical complications remained constant. Conclusion: Our database system, which is available free of charge, enables fast and accurate data entry. There were a relatively high number of (minor) complications in our series, but comparison with the relevant literature is difficult. This emphasises the need for a uniform definition of 'complication' as it relates to cochlear implant surgery, and an appropriate classification system for such complications.
    The Journal of laryngology and otology. 10/2014;
  • Rik C Nelissen, Emmanuel A M Mylanus, Myrthe K S Hol
    09/2014;
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    ABSTRACT: To compare the 3-year stability, survival, and tolerability of 2 osseointegrated implants for bone conduction hearing: a wide 4.5-mm-diameter moderately roughened implant with a rounded 6-mm abutment (test) and a 3.75-mm diameter as-machined implant with a conically shaped 5.5-mm abutment (control).
    07/2014;
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    ABSTRACT: To compare amplification options for patients with mixed hearing loss. Devices tested include percutaneous and transcutaneous bone conductors (BCDs) and middle ear implants with their actuator directly coupled to the cochlea. Tertiary academic medical center. Maximum output was studied with simulators. As simulators are lacking for the middle ear implants (the Vibrant Soundbridge [VSB] and the Cochlear's Direct Acoustic Cochlear Stimulator [Codacs]), the maximum output had to be measured in patients (4 and 5 patients, respectively). The maximum output averaged at 0.5, 1, and 2 kHz was the main outcome measure, which was expressed in dB HL, using appropriate transformation tables. The maximum output was the highest for the Codacs device and was above the patients' uncomfortable loudness levels. The maximum output of the VSB varied between 65 and 85 dB HL, and that of percutaneous BCD varied between 68 and 80 dB HL depending on the type of device. The transcutaneous BCD, the Sophono device, had the lowest output. Only with the Codacs device can the complete dynamic range be used. The maximum output of the VSB is lower and variable owing to the coupling to the cochlea. For patients with a sensorineural hearing loss component up to 50 dB HL, a percutaneous BCD forms a good treatment option that is completely independent of the middle ear status. The transcutaneous Sophono BCD is suitable for patients with a (sub-)normal sensorineural hearing loss component of 20 dB or less.
    Otology & neurotology: official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology 02/2014; 35(2):221-6. · 1.44 Impact Factor
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    Marloes Sparreboom, Andy J Beynon, Ad F M Snik, Emmanuel A M Mylanus
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    ABSTRACT: To assess the effect of sequential bilateral cochlear implantation on auditory, cortical maturation after various periods of unilateral cochlear implant use. Prospective cohort study. Tertiary academic referral center. Thirty prelingually deaf children, who received their first implant at a mean age of 1.8 years and their second implant at a mean age of 5.3 years. Sequential bilateral cochlear implantation. The electrically evoked auditory cortical response (EACR) was evoked by the 2 implants separately after 12 and 24 months of bilateral cochlear implant use. P1 and N2 latencies and RMS amplitudes were compared between both implant sides and were compared with those of a group of 27 age-matched children with normal hearing. EACR latencies diminished over time for both implant sides. RMS amplitudes and P1 latencies elicited by the second implant were still significantly different from that of the first implant after 24 month. After 24 months, the difference in N2 latencies between both implant sides was no longer significant, although still apparent. Interimplant delay had an adverse effect on RMS amplitudes and waveform morphology. EACR latencies were age appropriate, although RMS amplitudes evoked by the second implant were smaller than those of the children with normal hearing. Auditory cortical maturation is possible after extended unilateral cochlear implant use, although responses evoked by the second implant still lack behind that of the experienced first implant. It is not clear if the auditory cortical response will become similar on both implant sides over time, especially for the children with longer interimplant delays.
    Otology & neurotology: official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology 01/2014; 35(1):35-42. · 1.44 Impact Factor
  • Otology & neurotology: official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology 12/2013; · 1.44 Impact Factor
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    ABSTRACT: Objectives: To investigate the preservation of residual hearing in subjects who received the Nucleus Hybrid L24 cochlear implant. To investigate the performance benefits up to one year post-implantation in terms of speech recognition, sound quality, and quality of life. Design: Prospective, with sequential enrolment and within-subject comparisons. Post-operative performance using a Freedom Hybrid sound processor was compared with that of pre-operative hearing aids. Study sample: Sixty-six adult hearing-impaired subjects with bilateral severe-to-profound high frequency hearing loss. Results: Group median increase in air-conduction thresholds in the implanted ear for test frequencies 125-1000 Hz was < 15 dB across the population; both immediately and one year post-operatively. Eighty-eight percent of subjects used the Hybrid processor at one year post-op. Sixty-five percent of subjects had significant gain in speech recognition in quiet, and 73% in noise (≥ 20 percentage points/2 dB SNR). Mean SSQ subscale scores were significantly improved (+ 1.2, + 1.3, + 1.8 points, p < 0.001), as was mean HUI3 score (+ 0.117, p < 0.01). Combining residual hearing with CI gave 22-26 %age points mean benefit in speech recognition scores over CI alone (p < 0.01). Conclusions: Useful residual hearing was conserved in 88% of subjects. Speech perception was significantly improved over preoperative hearing aids, as was sound quality and quality of life.
    International journal of audiology 09/2013; · 1.34 Impact Factor
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    ABSTRACT: To confirm the clinical efficacy and safety of a direct acoustic cochlear implant. Prospective multicenter study. The study was performed at 3 university hospitals in Europe (Germany, The Netherlands, and Switzerland). Fifteen patients with severe-to-profound mixed hearing loss because of otosclerosis or previous failed stapes surgery. Implantation with a Codacs direct acoustic cochlear implant investigational device (ID) combined with a stapedotomy with a conventional stapes prosthesis MAIN OUTCOME MEASURES: Preoperative and postoperative (3 months after activation of the investigational direct acoustic cochlear implant) audiometric evaluation measuring conventional pure tone and speech audiometry, tympanometry, aided thresholds in sound field and hearing difficulty by the Abbreviated Profile of Hearing Aid Benefit questionnaire. The preoperative and postoperative air and bone conduction thresholds did not change significantly by the implantation with the investigational Direct Acoustic Cochlear Implant. The mean sound field thresholds (0.25-8 kHz) improved significantly by 48 dB. The word recognition scores (WRS) at 50, 65, and 80 dB SPL improved significantly by 30.4%, 75%, and 78.2%, respectively, after implantation with the investigational direct acoustic cochlear implant compared with the preoperative unaided condition. The difficulty in hearing, measured by the Abbreviated Profile of Hearing Aid Benefit, decreased by 27% after implantation with the investigational direct acoustic cochlear implant. Patients with moderate-to-severe mixed hearing loss because of otosclerosis can benefit substantially using the Codacs investigational device.
    Otology & neurotology: official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology 08/2013; · 1.44 Impact Factor
  • Arjan J Bosman, Ad F M Snik, Myrthe K S Hol, Emmanuel A M Mylanus
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    ABSTRACT: Background: The recent introduction of digital hearing aid technology for bone-conduction devices employing percutaneous stimulation may be beneficial for patients with conductive and mixed hearing loss and single sided deafness. Purpose: Performance of a recently released sound processor for bone-anchored implants, the Ponto Pro Power from Oticon Medical (bone-conduction device 2 [BCD2]), was compared with that of the Baha Intenso from Cochlear (bone-conduction device 1 [BCD1]). Research Design: Direct comparison of the subject's own device (BCD1) with the new device (BCD2) was examined in a nonrandomized design. Subjects were initially tested with BCD1. BCD2 was tested after a 4 wk acclimatization period. Study Sample: Eighteen subjects with mixed hearing loss and with at least 4 mo experience with BCD1 completed the study. Mean air-conduction and bone-conduction thresholds averaged across the frequencies of 500, 1000, 2000, and 4000 Hz were 73.9 and 34.2 dB HL, respectively. Data Collection and Analysis: Performance of the two devices was evaluated objectively by measuring aided free-field thresholds, speech perception in quiet, and speech perception in noise. A subjective evaluation was carried out with the Abbreviated Profile of Hearing Aid Benefit (APHAB) (Cox and Alexander, 1995) and the Speech, Spatial and Qualities of Hearing Scale (SSQ) questionnaire (Gatehouse and Noble, 2004). In addition, user experiences, user satisfaction, and device preference were obtained via proprietary questionnaires. Statistical significance was established with analysis-of-variance (ANOVA) and paired t-statistics with Bonferroni correction. Results: Aided free-field thresholds and speech reception thresholds (SRTs) in quiet were not statistically significantly different for either device (p > 0.05). In contrast, SRTs in noise were 2.0 dB lower (p < 0.001) for BCD2 than for BCD1. APHAB questionnaire scores on all subscales provided statistically significantly greater benefit (p < 0.05) for BCD2 than for BCD1. Also, with the SSQ most items in the speech and sound quality domain were significantly more favorable (p < 0.05) for BCD2 than for BCD1. Finally, all subjects preferred BCD2 over BCD1 with 14 subjects reporting a strong preference and four subjects an average preference for the digital signal processing provided by BCD2 over previous technology provided by BCD1.
    Journal of the American Academy of Audiology 06/2013; 24(6):505-13. · 1.63 Impact Factor
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    ABSTRACT: OBJECTIVES: Evaluation of a single-channel linear bone conduction implant sound processor (S-BCI) and a multiple-channel nonlinear bone conduction implant sound processor (M-BCI) with objective and subjective measures in patients with mixed hearing loss. STUDY DESIGN: In total, 20 patients with mixed hearing loss were included in the study. For either sound processor aided thresholds and speech perception in quiet with monosyllables were measured. Speech perception in noise was measured with sentences. Two different configurations were used: speech and noise at 0° (S0N0) and speech at 0° and noise at 180° (S0N180). The M-BCI was tested in both omnidirectional and directional mode. Patients were first fitted with the S-BCI and evaluated 3 weeks later. The M-BCI was fitted and, again 3 weeks later, evaluated. Subjectively, patients compared both sound processors with the APHAB questionnaire. RESULTS: Aided thresholds were similar for both sound processors in the low- and mid-frequency range. For speech in quiet, no significant differences between both sound processors were observed. For speech in noise in the S0N0 condition, the M-BCI-thresholds were 1.7 dB (SD, 2.2dB; p = 0.002) more favorable than with S-BCI. For the S0N180 configuration, an improvement of 5.8 dB (SD, 2.8dB; p < 0.001) was seen for the directional mode relative to S-BCI. The APHAB showed statistically significant subjective improvement with the M-BCI on all subscales relative to S-BCI. CONCLUSION: Speech intelligibility in noise is better with M-BCI than with S-BCI. This was attributed to better high-frequency gain provided by the M-BCI. Improved signal processing strategies may have contributed to subjective preference for the M-BCI.
    Otology & neurotology: official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology 04/2013; · 1.44 Impact Factor
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    ABSTRACT: To investigate the quality of life of people with an auricular prosthesis. A retrospective case series study was conducted. Quality of life was evaluated by an open-ended question form and 3 questionnaires: the Glasgow Benefit Inventory, the Rosenberg Self-Esteem scale, and the standard Medical Outcome Study Short-Form 12. The occurrence of peri-implant skin reactions (defined by Holgers), along with fixture stability and prosthesis data, were evaluated in 29 implants from 10 patients. The follow-up period varied between several months and more than 17 years. The 3 questionnaires showed an improvement in quality of life scores for all patients, and all patients would recommend the prosthesis. Skin reactions that needed treatment (ie, Holgers grades 2-4) were seen in 6.2% of all observations; 44.8% of the implants demonstrated either no reaction at all or redness only around the implant. A significant correlation was found between the Rosenberg Self-Esteem score and the number of prosthesis replacements. In general, patients seemed to be satisfied with the auricular prostheses, which did improve their quality of life. Furthermore, the quality of life was enhanced with higher quality prostheses and with proper hygiene to prevent skin reactions.
    The Journal of craniofacial surgery 03/2013; 24(2):392-7. · 0.81 Impact Factor
  • A Snik, E Mylanus
    Clinical otolaryngology: official journal of ENT-UK; official journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery 02/2013; 38(1):95-6. · 1.87 Impact Factor
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    ABSTRACT: Assessment of the clinical effectiveness of bilateral cochlear implantation compared with unilateral cochlear implantation or bimodal stimulation, in adults with severe-to-profound hearing loss. In 2007, the National Institute for Health and Clinical Excellence (NICE) in the U.K. conducted a systematic review on cochlear implantation. This study forms an update of the adult part of the NICE review. The electronic databases MEDLINE and Embase were searched for English language studies published between October 2006 and March 2011. Studies were included that compared bilateral cochlear implantation with unilateral cochlear implantation and/or with bimodal stimulation, in adults with severe-to-profound sensorineural hearing loss. Speech perception in quiet and in noise, sound localization and lateralization, speech production, health-related quality of life, and functional outcomes were analyzed. Data extraction forms were used to describe study characteristics and the level of evidence. Data Synthesis: The effect size was calculated to compare different outcome measures. Pooling of data was not possible because of the heterogeneity of the studies. As in the NICE review, the level of evidence of the included studies was low, although some of the additional studies showed less risk of bias. All studies showed a significant bilateral benefit in localization over unilateral cochlear implantation. Bilateral cochlear implants were beneficial for speech perception in noise under certain conditions and several self-reported measures. Most speech perception in quiet outcomes did not show a bilateral benefit. The current review provides additional evidence in favor of bilateral cochlear implantation, even in complex listening situations.
    Otology & neurotology: official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology 02/2013; 34(2):190-8. · 1.44 Impact Factor
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    ABSTRACT: This report provides the first short-term follow-up data on the Ponto bone-anchored hearing implant from our tertiary referral centre. Thirty-one consecutive patients with a mean age of 51 years who received the implant between October 2010 and December 2011 were included retrospectively in this study. Implant loss, skin reactions around the implant (according to Holgers' grading system), revision surgery, and abutment replacements were retrospectively gathered from the patients' files as objective outcome measures. To obtain information on subjective patient satisfaction, the Glasgow Benefit Inventory (GBI) was used. The mean follow-up period was 16.9 months (range 12.1-25.2 months). One implant was lost. Over a total of 94 follow-up visits, 21 skin reactions were observed in 16 patients: Holgers grade 1 (slight redness, no need for treatment) in 18.1 % of the visits,and grade 2 (redness and moist, needing conservative treatment) in 4.3 % of the visits. Four 6-mm abutments (12.9 %) were replaced for a 9-mm abutment during the follow-up period, of which one (3.2 %) was in combination with revision surgery. In one patient keloid formation around the implant was observed. The GBI revealed a moderate subjective benefit. The short-term results with these percutaneous implants demonstrate a clinically stable implant with a low percentage of skin reactions that require treatment. Long-term, prospective follow-up data are needed to draw firmer conclusions.
    Archives of Oto-Rhino-Laryngology 01/2013; · 1.29 Impact Factor
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    ABSTRACT: OBJECTIVE: To clinically evaluate the performance of a titanium percutaneous bone-anchored hearing implant (BAHI) using a 3-week healing period. Short-term implant survival, stability changes, and skin reactions are evaluated from the initial implantation to 6 months postimplantation. METHODS: Thirty patients eligible for a BAHI were included in an open, prospective clinical investigation. Implant stability quotient (ISQ) values were recorded using resonance frequency analysis (RFA) at the time of implantation and at 10 days; at 3, 6, and 12 weeks; and at 6 months after placement of the implant. Sound processor fitting was performed 3 weeks after implantation. Skin reactions were evaluated according to the Holgers classification. RESULTS: One implant was lost 3 days after implantation because of poor bone quality. No implant loss occurred in the remaining 29 patients (96.7%). The mean ISQ value at the time of implantation was 67.1 (range, 44-71). Compared with baseline, there was a significant dip of -2.2 ISQ units at 10 days (mean, 65.7; p = 0.0093). There was a positive change in mean ISQ compared with baseline over the subsequent visits. No reduction in mean ISQ values was observed after implant loading. Skin reactions were observed incidentally (mean over all visits, 9.7%) and were generally mild (Holgers Grade 1; mean 9.0%). An adverse skin reaction (Holgers Grade 2) was observed only once (mean, 0.7%). CONCLUSION: The current study suggests that loading the implant and 6-mm abutment with the sound processor at 3 weeks is safe. The stability of the implant as measured by ISQ values had reached its baseline value within 3 weeks after implantation. The degree of stability was not affected by implant loading. Only mild skin reactions were observed incidentally. This study supports the use of early loading at 3 weeks as current practice in healthy adults with good bone quality; thus, these adults can benefit from the rehabilitation of their hearing at an earlier stage.
    Otology & neurotology: official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology 11/2012; · 1.44 Impact Factor
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    ABSTRACT: To develop a transmastoid-posterior tympanotomy approach for the implantation of a penetrating auditory prosthesis in the most distal portion of the cochlear nerve. Animal studies suggest that penetrating cochlear nerve implants may overcome limitations of current cochlear implant systems. One step toward human implantation is the development of a suitable surgical approach. In computer-rendered 3-dimensional (3-D) models (based on micro-CT scans of 10 human temporal bones), we simulated trajectories through the most basal part of the cochlea that gave access to the most distal portion of the cochlear nerve with minimal damage to intracochlear structures. We determined their vectors with respect to the mid-modiolar axis and posterior round window edge and assessed if they intersected the chorda tympani nerve. The typical vector obtained with these 3-D models ran in an anterosuperior direction, through the inferior part of the facial recess and anterior round window edge. In 7 of 10 temporal bones, this trajectory intersected the chorda tympani nerve. Based on the vectors, dummy probes were implanted in 3 of 10 temporal bones, and the need for chorda tympani removal was confirmed in accordance with the 3-D models. Postoperative micro-CT scans revealed that all probes were successfully implanted in the cochlear nerve, whereas the osseous spiral lamina and basilar membrane were preserved. The vector for drilling and implantation found in this study can be used as a guideline for real-life surgery and, therefore, is another step toward the clinical implementation of cochlear nerve implants.
    Otology & neurotology: official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology 08/2012; 33(6):1027-33. · 1.44 Impact Factor
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    ABSTRACT: This study assesses soft tissue reactions and implant stability of 1,132 percutaneous titanium implants (970 patients) for bone conduction devices (BCDs). In addition, it examines BCD usage and comparisons between different patient groups. Retrospective survey. Mean follow-up time of 4.6 years. Tertiary care referral center. The surveyed cohort was divided into 3 different age groups (children, adults, and the elderly). In addition, 4 groups with variable loading times (i.e., the time between placement of the implant and loading the BCD sound processor) were identified as well as a subgroup of patients with mental retardation. Soft tissue reactions around the percutaneous implants as classified by the Holgers grading system, implant failure, and revision surgery rates. In 95.5% of the 7,415 observations of 1,132 implants, there were no adverse soft tissue reactions. Implant loss was 8.3%. Significantly more soft tissue reactions and implant failures were observed in children compared with adults and the elderly (p < 0.05). Implant survival was lower in patients with mental retardation compared with patients without mental retardation (p = 0.001). The loading time did not influence the occurrence of soft tissue reactions and implant survival rates. Children and patients with mental retardation are the most vulnerable to soft tissue reactions and implant losses. Additional and more frequent care needs to be given during outpatient consultations. Because loading as early as 3 to 5 weeks did not negatively affect skin reactions or implant survival, full BCD installation can occur earlier without risk.
    Otology & neurotology: official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology 02/2012; 33(2):192-8. · 1.44 Impact Factor
  • Marloes Sparreboom, Ad F M Snik, Emmanuel A M Mylanus
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    ABSTRACT: To assess the effect of sequential bilateral cochlear implantation in children on their quality of life (QoL). Prospective cohort-control study. Tertiary academic referral center. Thirty children with prelingual deafness underwent sequential bilateral cochlear implantation (mean age at first implant, 1.8 years; mean age at second implant, 5.3 years). Nine children with a unilateral cochlear implant were also included in the study. All children had prelingual deafness, had good implant performance, and had no benefit from a contralateral conventional hearing aid. The groups were matched on duration of unilateral implant use, chronological age, and degree of bilateral hearing loss. Sequential bilateral cochlear implantation. Quality of life was assessed before surgery of the second implant and after 12 and 24 months of bilateral implant use. In the children with a unilateral cochlear implant, QoL was assessed over time and was compared with the study group after 12 and 24 months. Six questionnaires were used to measure QoL: overall health status using a visual analog scale; the Health Utilities Index Mark 3 (HUI3); the Pediatric Quality of Life Inventory (PedsQL); the Glasgow Children's Benefit Inventory (GCBI); the Speech, Spatial, and Qualities of Hearing Scale (SSQ); and the Nijmegen Cochlear Implant Questionnaire (NCIQ). Results showed no significant gain in generic QoL measures associated with sequential bilateral cochlear implantation (P > .05). The nonsignificant effect yielded on the HUI3 could be attributed to the ceiling effect and the lack of resolution in the hearing domain obtained in cochlear implant recipients. The gain in QoL of +0.04 may, therefore, be underestimated. In contrast, the 3 disease-specific questionnaires showed a significant improvement in QoL (P < .05). Results also showed that, unlike the children with a unilateral implant, QoL measures continued to improve with longer durations of bilateral implant use. Within the study group, the age at second implantation had no influence on the gain in QoL (P > .05). Sequential bilateral cochlear implantation in children is associated with an improvement in QoL, although this is predominantly reflected in the disease-related aspects of QoL and not necessarily in generic QoL.
    Archives of otolaryngology--head & neck surgery 02/2012; 138(2):134-41. · 1.92 Impact Factor
  • Marloes Sparreboom, A Rens Leeuw, Ad F M Snik, Emmanuel A M Mylanus
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    ABSTRACT: The purpose of this study was (1) to measure parental expectations before surgery of a sequentially placed second cochlear implant and compare these results with parental observations postoperatively and (2) to measure device use of the second cochlear implant and compare to unilateral implant use. Thirty prelingually deaf children with a unilateral cochlear implant (mean age at first implant 1.8 years) received a second implant at a mean age of 5.3 years. To measure parental expectations and observations, parents completed the Parents' Perspective before surgery of the second implant and after 12 and 24 months. The questionnaire included 1 additional question on sound localization. Device use of both the first and second implants was assessed retrospectively after 6, 12 and 24 months of implant use. Device use of the study group was also compared to a reference group of 30 unilateral implant users matched for age at second implantation. Parental expectations with regard to sound localization were significantly higher than the observed changes within the first year of bilateral implant use. The observed changes in communication, listening to speech without lipreading, and speech and language skills met or surpassed parental expectations. Irrespective of age at second implantation, the second implant was significantly less worn than the first implant. No significant difference was observed between the use of the second implant of the study group and device use of the reference group. Second implant use was significantly correlated with the difference in speech recognition between the 2 implants alone. Preoperative parental expectations were too high with regard to the observed localization skills within the first year of bilateral implant use. The study showed that several of these sequentially implanted children had more difficulties in wearing the second implant than in wearing the first implant during the rehabilitation period. The present results suggest that this is caused by the dominant first implant performance. Such data are of high importance in order to provide parents with realistic counseling on what they can expect from sequential bilateral cochlear implantation.
    International journal of pediatric otorhinolaryngology 12/2011; 76(3):339-44. · 0.85 Impact Factor
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    ABSTRACT: Determination of the difference in implant stability between a novel Baha implant system (test) and the previous-generation implant system (control). In an open, randomized, prospective multicenter clinical investigation, 77 adult patients with Baha implants were included. Test and control implants were randomly assigned in proportions of 2:1. Implant stability quotient (ISQ) values were recorded using resonance frequency analysis at the time of implantation and at 10 days, at 4, 6, 8, and 12 weeks, and at 6 months after surgery. Skin reactions were evaluated according to the Holgers classification. Sound processor fitting was performed from 6 weeks after implantation. Significantly higher mean ISQ values, measured between 0 and 6 months, were obtained for test compared to control implants (70.4 versus 65.4, p < 0.0001). Statistically significant differences were obtained for the study population as a whole and for the subgroup of patients loaded at 6 ± 1 weeks after implant surgery (63.6% of patients). Up to 12 weeks, Holgers rates were comparable, whereas at 6 months, more skin reactions (Grades 1 and 2) were observed in the control implant group. No reduction in mean ISQ values was observed after implant loading. The test implant showed higher mean ISQ values at the time of placement and over time. The level of osseointegration reached with the implants in adults as early as 6 weeks after implantation was sufficient to support the sound processor. The test implant system is expected to provide additional benefits related to the improvement of the degree of osseointegration, especially for patients with thin or compromised bone.
    Otology & neurotology: official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology 06/2011; 32(6):1001-7. · 1.44 Impact Factor

Publication Stats

1k Citations
150.91 Total Impact Points

Institutions

  • 1995–2014
    • Radboud University Medical Centre (Radboudumc)
      • Department of Human Genetics
      Nymegen, Gelderland, Netherlands
  • 1998–2013
    • Radboud University Nijmegen
      • • Donders Institute for Brain, Cognition, and Behaviour
      • • Donders Centre of Neuroscience (DCN)
      • • Institute of Otorhinolaryngology
      Nijmegen, Provincie Gelderland, Netherlands
  • 2008
    • Het Van Weel-Bethesda Ziekenhuis
      Dirksland, South Holland, Netherlands
  • 2007
    • The University of Manchester
      Manchester, England, United Kingdom