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Hearing Loss, Sensorineural clinical trials

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NCT ID: NCT03143296 Completed - Clinical trials for Hearing Loss, Sensorineural

Reverberation Effects on MED-EL Recipients

Start date: August 16, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate speech understanding in simulated reverberant environments with MED-EL cochlear implant recipients.

NCT ID: NCT03112850 Completed - Clinical trials for Hearing Loss, Sensorineural

Cognition Effects of Hearing Aids and Auditory Training in Older Age

Start date: December 2016
Phase: N/A
Study type: Interventional

Sensorineural type of hearing loss is the most common sensory deficit among older adults. Some of the psychosocial consequences of this condition include difficulty in understanding speech, depression and social isolation. Studies have shown that older adults with hearing loss show some age-related cognitive decline. There is no clinically proven method to predict the onset of this condition, as its occurrence is slow and progressive, affecting both ears equally. Although hearing aid use and auditory training have been proven as successful interventions to alleviate sensorineural hearing loss, no research has been designed to look at the effect of both hearing aid use coupled with auditory training on cognitive performance in older adults. This study will investigate whether wearing hearing aids will improve the impact of auditory training on cognition, mood and social interaction for older adults with sensorineural hearing loss. This is a crossover trial targeting older adults between 50 and 90 years with either mild or moderate symmetric sensorineural hearing loss. Consented, willing participants will undergo a six month intensive auditory training program (active control), as a rigorous means of examining the impact hearing aid use has on a person's cognition, mood and social interaction. Participants will be assigned in random order to receive hearing aid (intervention) for either the first three or last three months of the six month auditory training program. Each participant will be tested at baseline, three and six months on a battery of computer based cognitive assessments, together with mood, and social engagement measures. Effectiveness of hearing aids and auditory training will be evaluated using an online speech perception test (SPT) and the Abbreviated Profile of Hearing Aid Benefit (APHAB) Inventory. This study will investigate whether using a hearing aid coupled with auditory training can improve a person's cognition and learning abilities, relationships with family and friends, and quality of life. Results from the study will inform strategies for aural rehabilitation, hearing aid delivery and future hearing loss intervention trials.

NCT ID: NCT03086135 Completed - Clinical trials for Conductive Hearing Loss

Clinical Performance of a New Implant System for Bone Conduction Hearing

Start date: March 9, 2017
Phase: N/A
Study type: Interventional

To study the initial experience with implanting and fitting the new Bone conduction system in patients with conductive, mixed or Single sided Sensorineural deafness.

NCT ID: NCT03031678 Completed - Clinical trials for Hearing Loss, Sensorineural

Electric-Acoustic Stimulation Extended Follow-up Post Approval Study

Start date: December 2016
Phase: N/A
Study type: Interventional

The MED-EL EAS Extended Follow-up Study is an extended follow-up of the subjects who were enrolled in the pivotal study to assess long-term safety and device performance.

NCT ID: NCT03022227 Completed - Clinical trials for Deafness; Perception, Bilateral

Feasibility of Remote Cochlear Implant Users' Follow-up

TELERIC1
Start date: May 2015
Phase: N/A
Study type: Interventional

Cochlear implants (CIs) are medical devices now widely used in persons with severe to profound hearing loss. After a six month to one-year period following implantation, adults typically reach optimal fitting parameters, which lead to a stabilized hearing performance with their CI. At this stage, they usually enter a routine clinical after-care program, which involves regular appointmentsattheir CI center. Such visits aim at identifying any complication, which can be medical (abnormal cutaneous healing evolution) and/or device related, as well as any declinein performance (possibly related to the former). In France, the HAS (French Health Authority) recommends CI users tobe seen around threetimes a year during the second and third years after implantation, and then annually. While the schedule of appointments remains dependent on centers' practices, there is some kind of consensus about the minimal content of a long-term follow-up session:medical consultation, CI external parts checking, free field aided tonal audiometry, fitting adjustments if necessary,speech understanding assessments. Our center (CRIC) is one of the biggest French CI implant centers approved by the HAS, providing after-care for no less than 750 CI users, most of whomhave entered their long-term follow-up period. For some, attending follow-up appointments may need several hours, require taking a half-day off work, and entail travel expenses. Some patients may also have associated disabilities making it difficultto reach the center.Moreover, although the cohort of patients has increased over the years, the number of trained professionals and the clinical care infrastructures have not evolved proportionally. As a consequence, there is a need to reduce the number of routine visits, to allow more scope for complex cases andto efficiently identify issues. Remote consultation seems to address all the points listed above. However, it appears that little has been doneto develop remote after-care for cochlear implant recipients. Published studies mainly focus on the fitting aspects. The development of telemedicine has become one of the key priorities of the French government over the past few years, and it is now feasible thanks to the development of high speed connections (ADSL, mobile internet, high definition transmissions). Promoting telemedicine has several goals, the main one being to extend health care services to underserved patients in remote locations; it also allows some medical units to be freed upand to reserve infrastructures and professionals for patients requesting critical care. Of course, telemedicine is also meant to save costs. The objectif of this protocole is to evaluate the feasibility of telemedicine applied to adult cochlear implant users' follow-up by comparing the data of the medical consultation and speech therapy assessment, carried out in the CRIC service and videoconferencing when the patient is home, using his computer equipment to communicate with the CRIC.

NCT ID: NCT03007472 Completed - Clinical trials for Hearing Loss, Sensorineural

Clinical Evaluation of the Cochlear Nucleus CI532 Cochlear Implant in Adults

SME
Start date: February 15, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to gather long-term data on the FDA approved CI532 cochlear implant, and CP1000 (Nucleus 7) sound processor

NCT ID: NCT02984202 Completed - Clinical trials for Deafness; Perception

Auditory Midbrain Implant Study

Start date: October 17, 2016
Phase: N/A
Study type: Interventional

The objectives of the clinical study are to implant five deaf patients (those with Neurofibromatosis Type II, NF2) with a new two-shank auditory midbrain implant array (AMI; developed by Cochlear Limited) into the central nucleus of the inferior colliculus in order to assess the safety, reliability, consistency of placement, and performance of the AMI device. The clinical trial is being performed at Hannover Medical School in Germany in collaboration with University of Minnesota (USA) and Cochlear Limited (Australia). The clinical trial is being managed by Hannover Clinical Trial Center in Germany.

NCT ID: NCT02948790 Completed - Clinical trials for Hearing Loss, Cochlear

Auditory Nerve Monitoring Using Intra-cochlear Stimulation in Subjects With Acoustic Neuroma

NeuriStim
Start date: April 7, 2017
Phase: N/A
Study type: Interventional

The aim of this study is to assess the auditory nerve functionality with an intraoperative approach following a surgical removal of acoustic neuroma in patients with severe to profound sensorineural hearing disabilities.

NCT ID: NCT02941627 Completed - Clinical trials for Hearing Loss, Sensorineural

The Neuro Zti Cochlear Implant System Efficacy and Safety in Adults

Start date: February 2, 2017
Phase: N/A
Study type: Interventional

The purpose of the study is to assess the efficacy and the safety profile of the Neuro Cochlear Implant System (CIS) in adults with severe-to-profound hearing loss.

NCT ID: NCT02925208 Completed - Clinical trials for Undergoing Cochlear Implant Surgery

Radiological Classification of the Facial Nerve

Start date: January 2010
Phase: N/A
Study type: Observational

Cortical mastoidectomy and posterior tympanotomy is a classic approach for cochlear implant. Intimate knowledge of the relevant surgical anatomy of the temporal bone and facial recess is important to safely perform the posterior tympanotomy. Anatomical variation of facial nerve such as lateral or anterior position of vertical segment of facial nerve, will render this approach challenging. In this research, investigators proposed a Radiological Classification system of the position of vertical segment of facial nerve in relation to the lateral semicircular canal to predict difficult cases with narrow facial recess.