No Difference in Behavioral and Self-Reported Outcomes for Simultaneous and Sequential Bilateral Cochlear Implantation: Evidence From a Multicenter Randomized Controlled Trial

Objective: The primary aim of this study was to longitudinally compare the behavioral and self-reported outcomes of simultaneous bilateral cochlear implantation (simBiCI) and sequential BiCI (seqBiCI) in adults with severe-to-profound postlingual sensorineural hearing loss.Design: This study is a multicenter randomized controlled trial with a 4-year follow-up period after the first moment of implantation. Participants were allocated by randomization to receive bilateral cochlear implants (CIs) either, simultaneously (simBiCI group) or sequentially with an inter-implant interval of 2 years (UCI/seqBiCI group). All sequential patients where encouraged to use their hearing aid on the non-implanted ear over of the first 2 years. Patients were followed-up on an annual basis. The primary outcome was speech perception in noise coming from a source directly in front of the patient. Other behavioral outcome measures were speech intelligibility-in-noise from spatially separated sources, localization and speech perception in quiet. Self-reported outcome measures encompassed questionnaires on quality of life, quality of hearing and tinnitus. All outcome measures were analyzed longitudinally using a linear or logistic regression analysis with an autoregressive residual covariance matrix (generalized estimating equations type).Results: Nineteen participants were randomly allocated to the simBiCI group and 19 participants to the UCI/seqBiCI group. Three participants in the UCI/seqBiCI group did not proceed with their second implantation and were therefore unavailable for follow-up. Both study groups performed equally well on speech perception in noise from a source directly in front of the patient longitudinally. During all 4 years of follow-up the UCI/seqBiCI group performed significantly worse compared to the simBiCI group on spatial speech perception in noise in the best performance situation (8.70 dB [3.96 – 13.44], p < 0.001) and localization abilities (largest difference 60 degrees configuration: -44.45% [-52.15 – -36.74], p < 0.0001). Furthermore, during all years of follow-up, the UCI/seqBiCI group performed significantly worse on quality of hearing and quality of life questionnaires. The years of unilateral CI use were the reason for the inferior results in the UCI/SeqBiCI group. One year after receiving CI2, the UCI/seqBiCI group performance did not statistically differ from the performance of the simBiCI group on all these outcomes. Furthermore, no longitudinal differences were seen in tinnitus burden prevalence between groups. Finally, the complications that occurred during this trial were infection, dysfunction of CI, facial nerve palsy, tinnitus and vertigo.Conclusion: This randomized controlled trial on bilaterally severely hearing impaired participants found a significantly worse longitudinal performance of UCI/seqBiCI compared to simBiCI on multiple behavioral and self-reported outcomes regarding speech perception in noise and localization abilities. This difference is associated with the inferior performance of the UCI/seqBiCI participants during the years of unilateral CI use. After receiving the second CI however, the performance of the UCI/seqBiCI group did not significantly differ from the simBiCI group.Trial Registration: Dutch Trial Register NTR1722

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IMPORTANCE The cost of bilateral cochlear implantation (BCI) is usually not reimbursed by insurance companies because of a lack of well-designed studies reporting the benefits of a second cochlear implant. OBJECTIVE To determine the benefits of simultaneous BCI compared with unilateral cochlear implantation (UCI) in adults with postlingual deafness. DESIGN, SETTING, AND PARTICIPANTS A multicenter randomized clinical trial was performed. The study took place in 5 Dutch tertiary referral centers: the University Medical Centers of Utrecht, Maastricht, Groningen, Leiden, and Nijmegen. Forty patients eligible for cochlear implantation met the study criteria and were included from January 12, 2010, through November 2, 2012. The main inclusion criteria were postlingual onset of hearing loss, age of 18 to 70 years, duration of hearing loss of less than 20 years, and a marginal hearing aid benefit. Two participants withdrew from the study before implantation. Nineteen participants were randomized to undergo UCI and 19 to undergo BCI. INTERVENTIONS The BCI group received 2 cochlear implants during 1 surgery. The UCI group received 1 cochlear implant. MAIN OUTCOMES AND MEASURES The primary outcome was the Utrecht Sentence Test with Adaptive Randomized Roving levels (speech in noise, both presented from straight ahead). Secondary outcomes were consonant-vowel-consonant words in silence, speech-intelligibility test with spatially separated sources (speech in noise from different directions), sound localization, and quality of hearing questionnaires. Before any data were collected, the hypothesis was that the BCI group would perform better on the objective and subjective tests that concerned speech intelligibility in noise and spatial hearing. RESULTS Thirty-eight patients were included in the study. Fifteen patients in the BCI group used hearing aids before implantation compared with 19 in the UCI group. Otherwise, there were no significant differences between the groups' baseline characteristics. At 1-year follow-up, there were no significant differences between groups on the Utrecht Sentence Test with Adaptive Randomized Roving levels (9.1 dB, UCI group; 8.2 dB, BCI group; P = .39) or the consonant-vowel-consonant test (median percentage correct score 85.0% in the UCI group and 86.8% in the BCI group; P = .21). The BCI group performed significantly better than the UCI group when noise came from different directions (median speech reception threshold in noise, 14.4 dB, BCI group; 5.6 dB, BCI group; P <.001). The BCI group was better able to localize sounds (median correct score of 50.0% at 60 degrees, UCI group; 96.7%, BCI group; P CONCLUSIONS AND RELEVANCE This randomized clinical trial demonstrates a significant benefit of simultaneous BCI above UCI in daily listening situations for adults with postlingual deafness

No Difference in Behavioral and Self-Reported Outcomes for Simultaneous and Sequential Bilateral Cochlear Implantation:Evidence From a Multicenter Randomized Controlled Trial

Objective: The primary aim of this study was to longitudinally compare the behavioral and self-reported outcomes of simultaneous bilateral cochlear implantation (simBiCI) and sequential BiCI (seqBiCI) in adults with severe-to-profound postlingual sensorineural hearing loss. Design: This study is a multicenter randomized controlled trial with a 4-year followup period after the first moment of implantation. Participants were allocated by randomization to receive bilateral cochlear implants (Cis) either, simultaneously (simBiCKI group) or sequentially with an inter-implant interval of 2 years (UCI/seqBiCI group). All sequential patients where encouraged to use their hearing aid on the non-implanted ear over of the first 2 years. Patients were followed-up on an annual basis. The primary outcome was speech perception in noise coming from a source directly in front of the patient. Other behavioral outcome measures were speech intelligibility-innoise from spatially separated sources, localization and speech perception in quiet. Self-reported outcome measures encompassed questionnaires on quality of life, quality of hearing and tinnitus. All outcome measures were analyzed longitudinally using a linear or logistic regression analysis with an autoregressive residual covariance matrix (generalized estimating equations type). Results: Nineteen participants were randomly allocated to the simBiCl group and 19 participants to the UCI/seqBiCI group. Three participants in the UCI/seqBiCI group did not proceed with their second implantation and were therefore unavailable for followup. Both study groups performed equally well on speech perception in noise from a source directly in front of the patient longitudinally. During all 4 years of follow-up the UCI/seqBiCI group performed significantly worse compared to the simBiCl group on spatial speech perception in noise in the best performance situation (8.70 dB [3.96 13.44], p <0.001) and localization abilities (largest difference 60 degrees configuration: -44.45% [-52.15 - -36.74], p <0.0001). Furthermore, during all years of follow-up, the UCI/seqBiCI group performed significantly worse on quality of hearing and quality of life questionnaires. The years of unilateral CI use were the reason for the inferior results in the UCI/SeqBiCI group. One year after receiving CI2, the UCI/seqBiCI group performance did not statistically differ from the performance of the simBiCl group on all these outcomes. Furthermore, no longitudinal differences were seen in tinnitus burden prevalence between groups. Finally, the complications that occurred during this trial were infection, dysfunction of CI, facial nerve palsy, tinnitus and vertigo. Conclusion: This randomized controlled trial on bilaterally severely hearing impaired participants found a significantly worse longitudinal performance of UCI/seqBiCI compared to simBiCI on multiple behavioral and self-reported outcomes regarding speech perception in noise and localization abilities. This difference is associated with the inferior performance of the UCI/seqBiCI participants during the years of unilateral CI use. After receiving the second CI however, the performance of the UCI/seqBiCI group did not significantly differ from the simBiCI group

Laryngeal tuberculosis presenting as a supraglottic carcinoma: a case report and review of the literature

<p>Abstract</p> <p>Introduction</p> <p>Laryngeal tuberculosis used to be a common complication in advanced pulmonary tuberculosis. However, it has become a rare occurrence in developed countries since the introduction of antituberculous agents. Moreover, the pattern of the disease has changed over the years. Nowadays, it more closely resembles a laryngeal carcinoma than any other laryngeal illness.</p> <p>Case presentation</p> <p>We describe the case of a 50-year-old Caucasian man who presented with the clinical picture of laryngeal cancer, but which turned out to be tuberculosis. We illustrate the difficulty of recognizing laryngeal tuberculosis both clinically and even with radiological examination.</p> <p>Conclusion</p> <p>Although laryngeal tuberculosis is uncommon, especially in developed countries, it still occurs and should be considered as a differential diagnosis in any laryngeal disease, in particular in the case of a laryngeal carcinoma.</p

Correlation between subjective and objective hearing tests after unilateral and bilateral cochlear implantation

Background: There are many methods for assessing hearing performance after cochlear implantation. Standard evaluations often encompass objective hearing tests only, while patients' subjective experiences gain importance in today's healthcare. The aim of the current study was to analyze the correlation between subjective (self-reported questionnaires) and objective (speech perception and localization) hearing test results in adult cochlear implant (CI) users. Secondary, the correlation between subjective and objective hearing tests was compared between bilateral and unilateral CI patients. Methods: Data for this study were prospectively collected as part of a multicentre randomized controlled trial. Thirty-eight postlingually deafened adult patients were randomly allocated to receive either unilateral (n = 19) or bilateral (n = 19) cochlear implantation. We used data gathered after one year of follow-up. We studied the correlation between objectively measured speech perception and localization skills on the one hand and related domains of the Speech, Spatial and Qualities of Hearing Scale (SSQ) and Nijmegen Cochlear Implant Questionnaire (NCIQ) on the other hand. We also compared these correlations between unilateral and bilateral CI users. Results: We found significant weak to moderate negative correlations between the subjective test results (speech domain of the SSQ and the advanced speech perception domain of the NCIQ) and the related objective speech perception in noise test results (r = -0.33 to -0.48). A significant moderate correlation was found between the subjective test results (spatial domain of the SSQ) and the related objective localization test results (r = 0.59). The correlations in the group of bilateral CI patients (r = -0.28 to -0.54) did not differ significantly from the correlations in the group of unilateral CI patients (r = 0.15 to -0.40). Conclusions: Current objective tests do not fully reflect subjective everyday listening situations. This study elucidates the importance and necessity of questionnaires in the evaluation of cochlear implantation. Therefore, it is advised to evaluate both objective and subjective tests in CI patients on a regular basis. Trial registration: This trial was registered on March 11, 2009 in the Dutch Trial Register. Trial registration number: NTR1722

Comparison Between Simulated and Actual Unilateral Hearing in Sequentially Implanted Cochlear Implant Users, a Cohort Study

Introduction: Previous studies have proven the effectiveness of bilateral cochlear implantation compared to unilateral cochlear implantation. In many of these studies the unilateral hearing situation was simulated by switching off one of the cochlear implants in bilateral cochlear implant users. In the current study we assess the accuracy of this test method. Does simulated unilateral hearing (switching off one cochlear implant) result in the same outcomes as real life unilateral hearing with one cochlear implant and a non-implanted contralateral ear? Study design: We assessed the outcomes of one arm of a multicenter randomized controlled trial. Methods: In the original trial, 38 postlingually deafened adults were randomly allocated to either simultaneous bilateral cochlear implantation or sequential bilateral cochlear implantation. In the current study we used the data of the sequentially implanted group (n = 19). The primary outcome was speech perception-in-noise from straight ahead. Secondary outcomes were speech perception-in-silence, speech intelligibility-in-noise from spatially separated sources and localization capabilities. A within-subjects design was used to compare the results of hearing with one cochlear implant and a non-implanted contralateral ear (1- and 2-year follow-up) with the results of switching off one cochlear implant after sequential bilateral implantation (3-year follow-up). Results: We found no significant differences on any of the objective outcomes after 1-, 2-, or 3-year follow-up. Conclusion: This study shows that simulating unilateral hearing by switching off one cochlear implant seems a reliable method to compare unilateral and bilateral hearing in bilaterally implanted patients. Clinical Trial Registration: Dutch Trial Register NTR1722

Predicting sequential bilateral cochlear implantation performance in postlingually deafened adults; A retrospective cohort study

OBJECTIVE : To identify which preoperative patient characteristics influence sequential bilateral cochlear implantation performance and to create a statistical model that predicts benefit. DESIGN : Multicentre retrospective cohort study. SETTING : All patients were operated in four academic teaching hospitals in Perth, Australia, and followed up by audiologists of the Ear Science Institute Australia. PARTICIPANTS : A total of 92 postlingually deafened adult patients who had undergone sequential cochlear implantations between 19 June 1990 and 14 March 2016 were included. Patients were excluded if the 12‐month follow‐up consonant‐nucleus‐consonant (CNC) phoneme score was missing. MAIN OUTCOME MEASURE : The effect of 18 preoperative factors on the CNC phoneme score in quiet (at 65 dB SPL) with the second cochlear implant (CI2) one year after implantation. RESULTS : Two factors were positively correlated to speech understanding with CI2: Wearing a hearing aid (HA) before receiving CI2 (r = 0.46, P = 0.00) and the maximum CNC phoneme score with the first CI (CI1) (r = 0.21, P = 0.05). Two factors were negatively correlated: the length of hearing loss before CI2 in the second implanted ear (r = −0.25, P = 0.02) and preoperative pure tone average (PTA) (0.5, 1, 2 kHz) before CI2 in the second implanted ear (r = −0.27, P = 0.01). The following model could be created: predicted CNC phoneme score with CI2 (%) = 16 + (44 * HA use before CI2 (yes)) − (0.22 * length of hearing loss before CI2 (years)) + (0.23 * CNC phoneme score with CI1 (%)). Because the effect of HA use before implantation played such a major role, we also created a model after exclusion of the HA factor: Predicted CNC phoneme score with CI2 (%) = 82 − (0.17 * length of hearing loss before CI2 (years)) − (0.27 * PTA in second implanted ear before CI2 (0.5, 1, 2 kHz)) + (0.20 * CNC phoneme score with CI1 (%)). CONCLUSION : Advanced age or a long interval between implantations does not necessarily lead to poor CI2 results. Patients who are successful HA users before CI2, who have a low PTA before CI2, a high CNC phoneme score with CI1 and a limited length of hearing loss before CI2, are likely to be successful CI2 recipients.wileyonlinelibrary.com/journal/coaam2018Speech-Language Pathology and Audiolog

Validation of the U-STARR with the AB-York crescent of sound, a new instrument to evaluate speech intelligibility in noise and spatial hearing skills

The Advanced Bionics ® (AB)-York crescent of sound is a new test setup that comprises speech intelligibility in noise and localization tests that represent everyday listening situations. One of its tests is the Sentence Test with Adaptive Randomized Roving levels (STARR) with sentences and noise both presented from straight ahead. For the Dutch population, we adopted the AB-York setup and replaced the English sentences with a validated set of Dutch sentences. The Dutch version of the STARR is called the Utrecht-STARR (U-STARR). This study primarily assesses the validity and reliability of the U-STARR compared to the Plomp test, which is the current Dutch gold standard for speech-in-noise testing. The outcome of both tests is a speech reception threshold in noise (SRTn). Secondary outcomes are the SRTn measured with sounds from spatially separated sources (SISSS) as well as sound localization capability. We tested 29 normal-hearing adults and 18 postlingually deafened adult patients with unilateral cochlear implants (CI). This study shows that the U-STARR is adequate and reliable and seems better suited for severely hearing-impaired persons than the conventional Plomp test. Further, CI patients have poor spatial listening skills, as demonstrated with the AB-York test