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Hearing Loss, Sensorineural clinical trials

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NCT ID: NCT05664100 Terminated - Clinical trials for Hearing Loss, Sensorineural

First in Human Safety Study of FX-345 in Adults With Sensorineural Hearing Loss

Start date: December 15, 2022
Phase: Phase 1
Study type: Interventional

This single-blind, placebo-controlled trial will be conducted to evaluate the safety of FX-345 administered as a single intratympanic injection in adults with acquired sensorineural hearing loss. The primary objectives are to assess the local safety, systemic safety, and pharmacokinetic (PK) profile to determine systemic exposure.

NCT ID: NCT05586555 Terminated - Clinical trials for Hearing Loss, Sensorineural

A Monocentric Study Evaluating Pupillometry as an Objective Measurement for CI Fittings

PupillOM
Start date: May 2, 2023
Phase: N/A
Study type: Interventional

This trial is a monocentric, prospective and controlled study of the pupil response to detect hearing threshold and comfortable loudness of normal-hearing (NH) and CI-subjects.

NCT ID: NCT03904420 Terminated - Clinical trials for Sensorineural Hearing Loss, Bilateral

An Evidence Based Delivery Model of Care for Newly Implanted Adult CI Recipients

Start date: February 26, 2019
Phase: N/A
Study type: Interventional

The clinical investigation is evaluating a new clinical model in a group of newly implanted subjects who have already been consented to CI surgery.

NCT ID: NCT03858647 Terminated - Clinical trials for Sensorineural Hearing Loss

Electrode Placement and Audiologic Outcomes With the Advanced Bionics HiFocus L23 Electrode

Start date: February 21, 2019
Phase:
Study type: Observational

The goal of this study is to measure patient performance after cochlear implantation with the Food and Drug Administration (FDA) approved Advanced Bionics HiFocus L23 device. The specific aims of the project are as follows: 1. To measure implant audiologic performance as defined by speech performance in standard cochlear implant speech test batteries. 2. To determine scalar location after insertion through either intraoperative or postoperative imaging and correlate this with audiologic outcomes. 3. To assess the rates of preservation of residual acoustic hearing and correlate those with scalar location as determined in specific aim 2 and audiologic performance as determined in specific aim 1. 4. To correlate speech outcomes with quality of life measures, as defined by validated questionnaires including the Tinnitus Handicap Index (THI), Speech and Spatial Qualities (SSQ) Questionnaire, and Nijmegen Questionnaire. 5. To evaluate intraoperative ease of insertion from the surgeon's perspective and correlate this with postoperative electrode location and audiologic performance.

NCT ID: NCT03382769 Terminated - Clinical trials for Hearing Loss, Sensorineural

Hearing Loss in Older Adults Study

Start date: March 27, 2019
Phase: N/A
Study type: Interventional

This is a prospective, 1:1 randomized controlled trial of immediate versus delayed cochlear implantation (CI) on hearing handicap, communicative function, loneliness, mental wellbeing, and cognitive functioning. Participants are randomized 1:1 to an immediate cochlear implant intervention group versus a hearing aid control intervention.

NCT ID: NCT03134989 Terminated - Clinical trials for Hearing Impairment, Sensorineural

Cochlear Response Telemetry and Hearing Preservation

CREST
Start date: December 22, 2017
Phase:
Study type: Interventional

The main purpose of this study is to monitor the response from the cochlea as the electrode is inserted during the operation to receive a cochlear implant. The Cochlear Response Telemetry tool aims to measure the response from the cells within the cochlea and may be useful in the future to help to improve the surgical technique and potentially help surgeons better preserve any natural hearing that is available. The measurements are obtained using the cochlear implant and sound processor while a sound is presented to the ear through an earphone (like an earplug) placed into the ear canal.

NCT ID: NCT03118375 Terminated - Clinical trials for Conductive and Sensorineural Hearing Loss

Super Power in BAI

Start date: April 12, 2017
Phase:
Study type: Observational

The purpose of this study is to assess the benefit of new super-power bone-anchored hearing aid (BAHA) processors in BAHA users. BAHAs are able to help people with mixed/conductive and single-sided hearing loss when they are unable to use or receive limited benefit from traditional hearing. Until recently, BAHAs were only recommended to people with up to a moderate hearing loss. New super-power BAHA processors may be able to help people who previously were not candidates for BAHAs or received limited benefit from them. The information collected in this study may lead to improved evaluation of and expanded treatment options for people considering BAHA. Different types of hearing tests will be used to compare the devices.

NCT ID: NCT03026829 Terminated - Clinical trials for Tinnitus, Hearing Loss, Cochlear Implant Users

Sound Therapy for Tinnitus Relief in Cochlear Implant Users

Start date: October 3, 2017
Phase: N/A
Study type: Interventional

The aim of this exploratory study is to evaluate the use and effectiveness of sound therapy for tinnitus relief in cochlear implant users with tinnitus. The sound therapy is a combination of tinnitus counselling and sound enrichment with the Cochlear Active Relief from Tinnitus (CART) firmware.

NCT ID: NCT02809118 Terminated - Clinical trials for Hearing Loss, Idiopathic Sudden Sensorineural

Efficacy and Safety of AM-111 as Acute Sudden Sensorineural Hearing Loss Treatment

ASSENT
Start date: June 2016
Phase: Phase 3
Study type: Interventional

The primary objective of the trial is the confirmation of the efficacy of AM-111 in the recovery of severe to profound idiopathic sudden sensorineural hearing loss (ISSNHL).

NCT ID: NCT02641795 Terminated - Clinical trials for Sensory Hearing Loss

Robotic Assisted Cochlear Implantation Feasibility Study

MIRACI
Start date: July 1, 2016
Phase: N/A
Study type: Interventional

A first in man clinical trial to asses the the use of am image guided robotic system to safely and effectively create a minimally invasive access tunnel to the middle ear cavity to allow access to the round window for cochlear implant electrode insertion.