Active clinical trials for "Deafness"

The prevalence of childhood hearing loss in rural Alaska is disproportionately high and predominately infection-related. With preventive screenings and access to health care, much of childhood hearing loss is preventable. Although state-mandated school screening helps identify children with hearing loss, loss to follow-up is pervasive and exacerbated by a scarcity of specialists in rural regions. A mixed methods cluster randomized trial conducted in northwest Alaska demonstrated that telemedicine can significantly reduce loss to follow-up. This stepped wedge trial, in partnership with Southcentral Foundation, will build on this existing work to develop a model that can be scaled in diverse environments. We will adapt and implement a new telemedicine intervention called Specialty Telemedicine Access for Referrals (STAR). This trial will be conducted in 3 regions in rural Alaska that represent multiple healthcare systems. Based on stakeholder feedback and evidence generated from the previous trial, an enhanced mobile health (mHealth) hearing screening will be implemented in all participating schools prior to the STAR intervention, and the telemedicine referral to specialty care (STAR intervention) will be moved from the clinic directly into the school. This stepped-wedge cluster randomized trial is part of a larger hybrid type 1 effectiveness-implementation trial. The stepped wedge trial will evaluate the effectiveness of the STAR intervention in reducing loss to follow-up from referred school hearing screening in 3 regions of Alaska: Kodiak, Petersburg and Lower Yukon (n=23 schools, ~2,015 K-12 students/year). The STAR Intervention will be compared to the standard referral of a letter home to families. Cluster randomization at the level of school will be performed, with schools (clusters) randomized to one of two sequences. The effectiveness outcome (i.e., proportion of children who receive follow-up) will be evaluated over three academic years (2023-2026), with STAR rolled out in a stepwise manner for each of the two sequences (academic year 2024-2025 for sequence 1 and academic year 2025-2026 for sequence 2). The control periods for each sequence will be academic year 2023-2024 for sequence 1 and academic years 2023-2024 and 2024-2025 for sequence 2. Enhanced screening will be rolled out to both sequences at the same time (i.e., non-randomized) beginning academic year 2023-2024. An implementation evaluation will be conducted to refine and adapt the enhanced hearing screening and STAR intervention throughout the trial. Implementation data will be collected starting academic year 2022-2023 and then annually for each of the subsequent years.

The investigators balance and balance related problems and exercise programs should be handled multi-dimensionally. In this study, the investigators' aim is to investigate the effect of dual task-oriented education with stroboscopic glasses on balance, functional mobility and general walking parameters in children with hearing impairment, despite conventional balance exercises. The study will be started when the consent form which prepared in accordance with the ethical committee conditions, explained and approved to all participants and their families. Participants aged 7-12 years, who have not undergone cochlear implant surgery, who can walk independently, have a hearing threshold of 75 decibels (dB) and above, and are diagnosed with congenital bilateral sensorineural hearing impairment will be included in the study. Hearing impaired children who have physical, visual impairment, lack of cooperation for the application and have any neurological problems (other than sensorineural hearing loss) or orthopedic problems that may affect their balance will not be included. Children who meet the inclusion criteria will be divided into three groups by block randomization method; as control (Group 1), conventional exercise balance (Group 2), dual task-oriented stroboscopic visual training group (Group 3) and a healthy control group (Group 4) without any disability will form the fourth group. Only assessments and scales will be applied to the participants in Group 1 and Group 4 at the beginning of the study and at the end of 12 weeks. Group 2 and Group 3 will be included in the exercise program twice a week for 40 minutes for 12 weeks. Conventional balance exercises are planned to be done in groups, and other trainings are planned with one-on-one therapist. Before starting exercise training, demographic characteristics such as dB values (specified in the health reports of), age (years), height (cm), body weight (kg) of the children included in the study will be recorded. At the beginning of the exercise training and at the end of the 12-week training; balance, functional mobility and gait, fall history and fear of falling, quality of life, hand-eye coordination will be evaluated. This study is important in terms of being an example for researches to be carried out for the hearing impaired or other disability groups and contributing to the exercise programs of the trainers working in this field.

This study evaluates the treatment efficacy of tinnitus in people with mild hearing loss. One-third of participants will use hearing aid, one-third of participants will use customized music, while the other one-third participants will receive no treatment (waiting list control).

Hearing loss is among the top service-connected disabilities in Veterans. Hearing aids are the primary intervention for hearing loss. Half of the hearing aids dispensed in the VA are to Veterans who are receiving replacement amplification. Many Veterans would like their replacement hearing aids mailed to them, but they are required to travel to the clinic so that the fit of the hearing aid can be verified. There are standard fitting procedures, such as those used in infants and children, that use a coupler to simulate the patient's real ear to verify the hearing aid fitting. The results of this study should determine the efficacy of a coupler-based hearing-aid fitting protocol that would not require the Veteran to attend the fitting appointment, thereby contributing to improved Veteran-Centric care.

The CochlearTM Osia®2 System was cleared by the Food and Drug Administration November 15, 2019 (K191921) for individuals aged 12 years and older who present with conductive or mixed hearing loss (up to 55 dB HL) or single-sided-deafness (SSD).Published and unpublished data suggest significant pre to postoperative benefit and minimal risk in both children and adults who have received the Osia system. Thus the objective of this study is to examine the safety and effectiveness of the Cochlear Osia 2 system in a group of pediatric subjects aged 5 to 11 years who suffer from conductive or mixed hearing loss (up to 55 dB HL), or single-sided-deafness (SSD) with the intent of expanding the indications for use.

Children with profound sensorineural unilateral hearing loss (UHL) lag behind in spoken language, cognition, spatial hearing, and academic performance compared to normal hearing (NH) children. Until recently children with UHL were not remediated, thereby assuming that the normal ear would provide sufficient sensory cues for speech understanding. However, this is not true. Because of the difference between the two ears they have difficulty localizing sounds and understanding speech in noise. Such auditory deprivation leads to more global changes in neurocognitive function. It is expected that a cochlear implant in the deaf ear will provide the necessary cues for hearing with two ears. The main objective of this research project is to fundamentally investigate language, cognitive, and spatial/binaural hearing longitudinally in children with unilateral deafness who receive a cochlear implant and age-matched peers.

An evaluation of Cochlear's cochlear implant electrode array which passively elutes dexamethasone for a defined period of time to help reduce inflammatory responses.

This is an open-label, multi-centre study in subjects with a genetically confirmed mitochondrial deoxyribonucleic acid (DNA) transfer ribonucleic acid (tRNA)Leu(UUR) m.3243A>G mutation who completed study KH176-202. In the KH176-203 study subjects will be receiving KH176 100 mg BID or KH176 50 mg bid in die (BID) (as determined by the investigator based on safety / tolerability considerations) for a year, thereby ensuring continued treatment with KH176 after study KH176-202. A final follow-up visit is scheduled 4 weeks after the intake of the last dose of study medication for patients not rolling over into the compassionate use program. Primary safety data and secondary efficacy (endpoint) data will be monitored and reviewed every three months by an independent Data Safety Monitoring Board (DSMB) to evaluate potential risks and benefits.

Hearing loss and cognitive impairment both appear in elderly patients. The goal was to use a modified screening method added to already established cognitive tests to obtain a standardized test for detection of cognitive impairment in patients with hearing loss. The aim of this study is to collect data with neuropsychological tests using questionnaires and to determine cognitive impairment in patients with hearing loss. The collected data will be evaluated using SPSS 23. The corrected item-total correlation and item difficulty of the item DemTectEar will be assessed by item analysis / Cronbachs' Alpha. For further evaluation and comparisons two-sided t-tests with a level of significance 0.05 or Mann-Whitney-U-tests will be performed.

The purpose of this study is to evaluate short and long term outcomes (benefits and side-effects) of bilateral cochlear implantation and bilateral hearing aid rehabilitation in Finnish children.