View clinical trials related to Hearing Loss, Unilateral.
Filter by:Prospective, non-randomized, open-label study to evaluate the safety and efficacy of the iotaSOFT Insertion System when used to assist electrode array insertion during cochlear implant surgery in a pediatric population.
Children who are deaf or hard-of-hearing (D/HH) are at risk of speech and language delays, which can be mitigated through early identification and intervention. Identifying hearing loss (HL) during preschool is crucial, but the most effective hearing screening method for preschoolers remains uncertain. The purpose of this study is to learn whether, compared to the gold-standard two-stage Pure-tone audiometry (PTA) + otoacoustic emissions (OAE) screening (TS-PO), single-stage OAE (SS-O) screening alone is not inferior at identifying hearing loss when performed in a community-based preschool setting. This study holds the potential to improve early hearing loss detection and intervention among D/HH children, reducing the likelihood of speech and language delays. A diverse group of 28,000 preschool-age children across community-based preschool centers will be recruited. The intervention involves all subjects undergoing both PTA and OAE screening, with the order determined through randomization. Children who show potential hearing issues based on screening results or teacher concerns will receive further testing to determine the final hearing outcome. Group allocation will be post-hoc, based on their screening results. In addition to the primary objective, the study will compare other hearing screening measures and outcomes between the two methods (TS-PO and SS-O). This approach aims to reflect the real-life effectiveness of hearing screening in a diverse population. Ultimately, the study seeks to provide insights into an optimal hearing screening method that could prevent speech and language delays among D/HH children.
The goal of this clinical trial is to investigate the safety and effectiveness of cochlear implantation in infants and toddlers with single-sided deafness. The main questions it aims to answer are: - Are cochlear implants an effective treatment of single-sided deafness in infants and toddlers? - Are cochlear implants a safe treatment for single-sided deafness in infants and toddlers? Participants will receive a cochlear implant and be followed until they are five years old. During those five years, the investigators will program the device and monitor auditory development. Children will be asked to: - Undergo cochlear implantation - Wear their cochlear implant processor whenever they are awake. - Participate in traditional hearing tests - Participate in traditional hearing testing - Participate in localization testing - Participate in hearing in noise testing - Participate in word recognition testing - Participate in speech, language, and educational evaluations The researchers will compare results to children with typical hearing in both ears and children with single-sided deafness who have not received an implant to observe any differences between the groups.
Single-sided deafness (SSD) refers to severe to profound sensorineural hearing loss on one side (average pure-tone hearing threshold≥70 dB HL at 0.5, 1, 2, and 4kHz) while the opposite side maintains normal hearing or mild hearing loss (30 dB HL). Asymmetrical hearing loss (AHL) refers to severe to profound sensorineural hearing loss in the bad ear (average pure-tone hearing threshold≥70 dB HL at 0.5, 1, 2, and 4kHz) and mild to moderate hearing loss in the contralateral ear. Moderate hearing loss (30≤mean pure-tone hearing threshold≤55dBHL). It is generally acknowledged that SSD is a particular clinical manifestation of AHL. The number of people who have hearing loss accounts for 5.3% of the total population, with children for 9%. According to the Second National Sampling Survey on Disabled Persons, China has 27.8 million people with hearing disabilities. The incidence of SSD adults in the United States is 7.2%, with 60,000 new cases per year, compared with 7,500 new patients with SSD annually in the UK. The incidence of SSD in neonates is 0.04%-0.34%, and it ranges from 0.1% to 0.5% in children and adolescents. The etiology of congenital SSD is primarily unknown, which is related to genes. Among the causes of acquired SSD, sudden deafness is the most common. Other causes include head trauma, Meniere's disease, labyrinthitis, unilateral acoustic neuroma, middle ear surgery, ototoxic drug exposure, Virus infection, noise-induced deafness, senile deafness, etc. SSD and AHL impede intellectual development and speech development in children and adolescents, which is associated with the side of hearing loss. For example, children with right-sided hearing loss have relatively poor language learning, logical thinking, and divergent thinking. In contrast, children with left-sided hearing loss have weaker analytical, comprehensive and visual memory abilities and relatively poor spatial imagination and visual-motor coordination. In addition, the lack of long-term monaural listening and sound source localization makes SSD children require excessive concentration, which is prone to fatigue and behavioral problems, and their academic performance is lower than that of normal children.
The study is a non-interventional, observational, cross-sectional, study on users of Ponto sound processors. The purpose of this study is to evaluate subjectively assessed hearing performance and satisfaction with Oticon Medical's sound processors fitted with the Genie Medical fitting software.
The aim of the study is to assess the continued efficacy and safety of cochlear implantation in participants aged 5 years and above with Unilateral Hearing Loss (UHL)/Single Sided Deafness (SSD) supporting a change indication for use.
The purpose of this study is to evaluate the safety and effectiveness of cochlear implantation in adults 65 years of age and older.
Project synopsis: This prospective cohort study investigates impact of (1) hearing loss and (2) cochlear implantation on cost and health state on one hand, and employment, productivity and social wellbeing on the other hand in a professionally active group using validated questionnaires. Participants: The investigators aim to include 100 professional active adults between 18 and 65 years old. All participants have a bilateral severe-to-profound sensorineural or mixed hearing loss. Due to several reasons such as an optimal hearing aid fitting, the presence of a residual hearing or physical contra-indications, half of these participants will not be implanted with CI. Additionally, 100 participants with a single-sides deafness (SSD) in the acute or chronic setting (SDD present for at least three months) will be included. Study design Study measures: All audiological tests and patient-reported outcome measures will be included in this test protocol and repeated throughout the follow-up visits depending on aided or unaided setting. The cognitive evaluation will be executed during the first and last test moment. The investigators anticipate that the protocol will take 1 hour per follow-up in the hospital (audiological testing and to go over the questionnaires), plus an extra hour at home to fill out the questionnaires. For the cognitive tests, an extra hour in the hospital will be scheduled. Hypothesis As a primary endpoint, the investigators anticipate demonstrating that severe-to-profound hearing loss has a significant impact on sick leave and self-reported productivity. Health state will also be analyzed as a secondary endpoint because the investigators anticipate only marginal improvement (if any) on these instruments due to the lack of sensitivity and responsiveness, even in this population. The investigators will also determine the rate of usage and non-usage at this long-term follow-up to demonstrate the utility of cochlear implants. Statistical analysis IBM SPSS Statistics (IBM; Armonk, NY) will be used for the statistical analyses. The participants' hearing profiles will be summarized using descriptive statistics (median, and range). In view of the sample size, non-parametric tests and linear mixed models (to describe evolution in time and difference between groups) will be used. Quantitative data will be presented as median and range (minimum and maximum). Descriptives will be used to summarize the outcomes of the subjective data logging. For the speech perception in noise results, a Wilcoxon signed-rank test will be used. In addition, to correct for the multiple speech in noise test configurations, Holm's correction will be applied. The level of significance will be set at p.0.05. Data storage REDCap (Research Electronic Data Capture) is a secure, web-based application designed exclusively to support data capture for research studies. REDCap provides an interface for data entry (with data validation) and audit trails for tracking data manipulation and export procedures. Data will be pseudomized before storage in REDCap.
The primary objective of the study is to evaluate OID hearing intervention on cognition among patients who could vs. do utilize an OID. We will also evaluate the long-term effects of OID use on secondary outcomes measures (hearing performance, quality-of-life, social interaction, communication, physical functioning, etc)
The study is part of the Post Market Clinical Follow (PMCF) activity. The investigational device is the CE-marked Ponto 3 SuperPower (available on the market since December 2016) already fitted to the subjects, and data is collected retrospectively from clinical routine visits. The study is a retrospective study. Therefore there will be no study visits for treatment or follow-up in the study. Subject inclusion for this clinical investigation will be performed among subjects who has been fitted with the Ponto 3 SuperPower. To have a wide representative selection of subjects, enrollment will be spread over the 4 years since the device was available on the market since December 2016. The endpoints in the study will investigate the improvement of hearing with the Ponto 3 SuperPower. The data will be collected from the subjects in the time period from the clinical routine visit where the Ponto 3 SuperPower where fitted or just prior, and from the clinical routine visit following the fitting, where audiologic fitting follow-up procedures are performed (approximately 3 months).