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Hearing Loss, Sensorineural clinical trials

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NCT ID: NCT06459765 Recruiting - Clinical trials for Hearing Loss, Sensorineural

Mi2000 Totally Implantable Cochlear Implant (Mi2000 TICI)

Start date: June 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test the Mi2000 Totally Implantable Cochlear Implant in a population of candidates for a cochlear implant. The main question it aims to answer is, whether the device is able to improve speech perception compared to the pre-operative score. Participants will undergo cochlear implantation and fitting, and will be asked to perform the following tests pre- and post-operatively: - Word test in quiet - Sentence test in noise - Audiograms - Health Utilities Index 2 and 3 (HUI2&3), a generic quality-of-life questionnaire - Nijmengen Cochlear Implant Questionnaire (NCIQ), a disease specific quality-of life questionnaire - Speech, Spatial and Qualities of Hearing Scale (SSQ12), a disease specific questionnaire - Hearing Implant Sound Quality Index (HISQUI19), a sound quality questionnaire

NCT ID: NCT06434129 Recruiting - Clinical trials for Sensorineural Hearing Loss

Role of Diffusion Tensor-magnetic Resonance Imaging in Investigating Sensorineural Hearing Loss

Start date: October 1, 2023
Phase:
Study type: Observational

DTI and auditory tractography can be incorporated into the diagnostic toolkit for patients who are scheduled to undergo cochlear implantation and whose standard assessments have been unable to determine the functional integrity of the auditory pathway. These techniques aid in decision-making processes regarding potential outcomes, determining the optimal side for implantation, providing counseling regarding the possibility of limited benefits from surgery, and considering alternative forms of rehabilitation. The investigators including patients with varying degrees of hearing loss, as well as patients with normal radiological findings who are scheduled for cochlear implantation. The ultimate goal is to create a comprehensive map across the entire hearing spectrum and validate the findings of this study..

NCT ID: NCT06420037 Recruiting - Clinical trials for Hearing Loss, Sensorineural

The Influence of the Individual Auditory-cognitive Need on the Aided Benefit Using Different Feature Settings

Start date: November 1, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to optimize hearing aid benefit based on the individual auditory-cognitive need using different hearing aid features in first-time hearing aid users between 45-80 years old with bilateral Phonak Audéo Paradise/Lumity 70 hearing aids. The main questions it aims to answer are: Does cognitive functioning affect hearing aid benefit? How can hearing aid fitting be optimized based on the individual auditory-cognitive profile? The hypothesis posits that cognitive abilities influence the effectiveness of hearing aids, alongside hearing status. Furthermore, if features of hearing aids improve speech understanding and listening effort, it is proposed that individuals with lower cognitive functioning will experience heightened benefits from hearing aids. The study will consist of three groups: one control group and two groups where one different feature will be modified. Participants will be tested at baseline measurement, including: - screening tests - audiological tests - questionnaires - cognitive tests - real-ear-measurement Following this, participants will be divided in one of the three groups, after which speech audiometry will be repeated. After a 4-week acclimatization period, the second measurement will take place, repeating speech audiometry and questionnaires. Subsequently, the hearing aid settings will be restored to their initial configuration.

NCT ID: NCT06301581 Recruiting - Clinical trials for Cochlear Hearing Loss

Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant

Start date: January 22, 2024
Phase:
Study type: Observational

This is a retrospective study designed to collect speech perception results for HiRes Ultra CI and HiRes Ultra 3D CI users as measured in the clinical routine and to confirm the performance of these devices.

NCT ID: NCT06301568 Recruiting - Clinical trials for Cochlear Hearing Loss

Retrospective Analysis of Long-term Speech Performance in Cochlear Implant Recipients Using Electro-acoustic Stimulation

Start date: January 22, 2024
Phase:
Study type: Observational

This is a retrospective study designed to collect long-term speech perception results for cochlear implants recipients using electro-acoustic-stimulation as measured in the clinical routine and to confirm the performance of sound processors associated with acoustic earhooks.

NCT ID: NCT06298396 Recruiting - Clinical trials for Hearing Loss, Sensorineural

Investigating Stimulation Parameter and Electrode Mode Changes on Speech Perception in Experienced Adult Cochlear Implant Recipients

DUAL
Start date: May 27, 2024
Phase: N/A
Study type: Interventional

This study aims to investigate the effect of stimulation parameters and different electrode modes on speech perception in adult cochlear implant recipients.

NCT ID: NCT06278129 Recruiting - Meniere Disease Clinical Trials

Evaluation of the Diagnostic and Prognostic Efficacy of MRI in Acute Sensorineural Hearing Loss and Ménière's Disease

MRI_SSHL/MD
Start date: June 19, 2018
Phase:
Study type: Observational

Evaluation of the diagnostic and prognostic efficacy of nuclear magnetic resonance imaging in patients with acute sensorineural hearing loss or in patients suffering from probable or definite MD. The neuroradiological and audiological evaluation are held on in the same day in order to better clarify the radiological and clinical correlates.

NCT ID: NCT06249919 Recruiting - Clinical trials for Sudden Sensorineural Hearing Loss

A Phase 1b/2a, Study Evaluating the Safety, PK/PD and Efficacy of NS101 in Healthy Volunteers and SSNHL Patients

Start date: January 19, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this 2 step-up, exploratory study is to test safey, tolerability and PK/PD profiles in healthy volunteers and safety, tolerability and efficacy in sudden sensorineural hearing loss patients as an early salvage therapy. The main questions it aims to answer are: 1. whether is it safe and tolerable when healthy volunteers and sudden sensorineural hearing loss patients take multiple doses of NS101 against FAM19A5 2. whether is it effective in reversing hearing capability in sudden sensorineural hearing loss patients who fails to show sufficient recovery despite of oral standard steroid therapy. Patients and heathly volunteers will be given NS101 15mg/kg or 30mg/kg systemically less than 3 months per protocol. This is placebo controlled, double blinded study, which means there will be a group who receives placebo (i.e. fake drug) for study purpose.

NCT ID: NCT06226558 Recruiting - Clinical trials for Sensorineural Hearing Loss

Long-Term Outcomes of Children With Congenital CMV in New York State

PROACTIVE NYS
Start date: February 1, 2024
Phase:
Study type: Observational [Patient Registry]

PROACTIVE NYS is a long-term follow-up study of all infants who test positive for congenital Cytomegalovirus infection (CMV) throughout New York State on the Newborn Screen. By following all infants who screen positive, we will learn important information about the range of symptoms caused by congenital CMV, from those babies with more severe findings to those with no symptoms. In particular, our study will provide new information about many facets of congenital CMV, including: - Developmental, hearing, neurologic, and vision outcomes - The spectrum and timing of symptoms - The impact congenital CMV has on the baby and its family - How many babies are infected with congenital CMV in New York State How antiviral medications and other interventions impact outcomes of children with congenital CMV Throughout the duration of the study, children will undergo routine developmental and hearing assessments, which will assist with early diagnosis of any infection complications. Any child found to have a neurodevelopmental, hearing, or vision abnormality will be referred for appropriate evaluation and treatment. Families will also be asked to complete periodic surveys about their experience with congenital CMV, both as a medical diagnosis and as it affects their day-to-day activities.

NCT ID: NCT06223724 Recruiting - Clinical trials for Sensorineural Hearing Loss

Status Telemetry for Cochlear Implantations

PATHOS
Start date: October 25, 2023
Phase:
Study type: Observational

Cochlear implants (CIs) are well-established neuroprosthesis used to restore hearing for patients with partial or complete deafness. However, the audiological outcomes of these implants can vary widely, and one reason for this is suboptimal electrode placement. The gold standard for measuring electrode positions is computed tomography (CT) scans, but they are expensive and expose patients to additional radiation, which is especially harmful for children. This study investigates an alternative approach using impedance telemetry data to estimate electrode positions without exposing patients to radiation. For this purpose, an extended telemetry version of a CE-certified cochlear implant software is used. The advanced impedance telemetry software can measure impedance subcomponents with improved measurement resolution that could be used for more accurate estimation of electrode insertion depth using specially designed estimation software. Ultimately, the investigators want to demonstrate the potential to improve audiological outcomes of cochlear implant recipients without exposing them to additional radiation.