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Hearing Loss, Bilateral clinical trials

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NCT ID: NCT05540535 Active, not recruiting - Healthy Aging Clinical Trials

Dual-Task Cost in Bilateral Hearing Loss

Start date: February 1, 2022
Phase:
Study type: Observational

The specific aims of the research study are: 1. Compare single-task gait parameters between individuals with hearing loss (HL) and age and education matched controls with normal hearing [normal vs moderate-profound hearing loss (N=23 for each group)]. For that we will compare the primary outcome measure, gait speed, between the groups while participants are walking at a comfortable speed for 1 minute. 2. Compare cognitive function between individuals with HL and age and education matched controls. For that we will compare the Neurocognitive Index, derived from a cognitive assessment between groups. 3. Compare the effect of a cognitive task while walking on gait parameters between people with HL and age education matched controls with normal hearing. For that we will compare the primary outcome measure, gait speed, between groups while participants are walking at a comfortable speed and counting backwards [serial subtraction of 3] for 1 minute. 4. Explore whether cognitive performance (i.e., the Neurocognitive Index) is correlated with Dual task cost (DTC), a deterioration of gait speed while walking and performing concurrent cognitive task [serial subtraction of 3]. The formula to calculate this is the following: DTC = 100 X [(DT - single task)/ single task].

NCT ID: NCT05525221 Recruiting - Clinical trials for Hearing Loss, Sensorineural

Societal Merit of Intervention on Hearing Loss Evaluation

SMILE
Start date: June 29, 2020
Phase:
Study type: Observational

The primary objective of this study is to determine the (long term) effect of intervention with a CI in adult participants with progressive postlingual moderate/severe-to-profound sensorineural hearing loss on societal related outcomes (participation; communication profile; autonomy; cognition; listening effort; work; productivity loss; income; medical consumption; third party quality of life; quality of life, and capability). The secondary objective is to determine the effect of CI waiting time between referral and CI surgery on the same societal related outcomes, in the adults with postlingual moderate/severe-to-profound sensorineural hearing loss.

NCT ID: NCT05521308 Completed - Clinical trials for Hearing Loss, Sensorineural

Investigating Hearing Aid Frequency Response Curves

Start date: October 24, 2022
Phase: N/A
Study type: Interventional

Internal research on the manufacturer's hearing aid products has idenitfied areas in which the investigators can improve the hearing aid frequency response curve. This study aims to investigate the current freqeuncy response curve in the manufacturer's products to variations of these curves to determine if hearing aid users prefer the variations over the manufacturer's standard curve.

NCT ID: NCT05402813 Recruiting - Clinical trials for Sensorineural Hearing Loss, Bilateral

Natural History in Children up to 10 Years With Moderate to Profound Hearing Loss Due to Mutations in GJB2 / OTOF Genes

Otoconex
Start date: November 18, 2022
Phase:
Study type: Observational

The purpose of this study is to follow the natural history of non-syndromic hearing loss caused by mutations in two genes (GJB2 or OTOF) in children up to 10 years of age.

NCT ID: NCT05369598 Recruiting - Cochlear Implants Clinical Trials

Audiological and Quality of Life Outcomes of Anatomy Based Fitting in Patients Implanted by Robot Assisted Cochlear Implant Surgery (RACIS)

RACIS ABF
Start date: March 1, 2022
Phase: N/A
Study type: Interventional

Severe to profound hearing loss affects 0,8% of the global population. For these people, a conventional hearing aid often does not provide sufficient benefit. However, these people can benefit from a cochlear implant (CI). A CI needs to be individually programmed (fitted) for each recipient. A fitting "map" is defined as a set of electrical parameters that are individually adapted to a recipient's needs to achieve optimal sound perception. At present, most CI recipients are fitted with a default frequency allocation map that doesn't take individual variability in size and shape of the cochlea into account. In this study, a fitting strategy based on the post-operative CT scan, that will allow the audiologist to set a frequency-band distribution for CI fitting that may be more closely aligned to the natural tonotopic frequency distribution of a normal hearing cochlea, will be evaluated. This study will focus on patients that are already implanted with the HEARO robotic system.

NCT ID: NCT05307952 Recruiting - Deafness, Bilateral Clinical Trials

Auditory Diagnostics and Error-based Treatment

AuDiET
Start date: May 30, 2022
Phase: N/A
Study type: Interventional

The main objective of this study is to assess the effectiveness of an integrated program of fitting and training interventions aimed at reducing unexpected variability and addressing the specific error patterns of each recipient. The participants will undergo 1 visit lasting approximately 2 hours at the Radboud university medical center's ENT department, where they will undergo a series of diagnostic tests. Some of the participants will also be asked to self-administer additional tests using a Windows tablet. Based on the outcomes of speech recognition tests in quiet at the first visit, the participants will be called for follow-up interventions concerning both the fitting of their CI and personalized auditory training based on their personal error patterns. These interventions will take place over the course of approximately 5 months and will be made up of three follow-up visits and a period of self-administered training through a mobile application on a tablet. One final follow-up visit will check whether any changes from the interventions are retained after four weeks.

NCT ID: NCT05299892 Completed - Clinical trials for Hearing Loss, Sensorineural

Optimizing Soft Speech Recognition in Children With Hearing Loss

SoftSpeech
Start date: March 21, 2022
Phase: N/A
Study type: Interventional

Overhearing is important for vocabulary learning and speech and language development in young children. However, contemporary hearing aids are generally unable to provide adequate access to low-level auditory inputs from multiple talkers at a distance to capitalize on overhearing. A recent investigation by Jace Wolfe and colleagues showed that, even when aided, children with hearing loss had significantly poorer speech recognition at 40, 50 and 60 dBA compared to children with normal hearing. Furthermore, they showed that increasing hearing aid gain for very low-level inputs produced a statistically significant improvement in syllable-final plural recognition and a non-significant trend toward better monosyllabic word recognition at very low presentation levels. Additional research is needed to document low-level speech recognition ability of children with hearing loss as well as the potential benefit or detriment of increasing hearing aid gain for low-level inputs. A novel hearing aid technology known as Soft Speech Enhancer has been shown improve low-level speech perception in adults with hearing loss; however, the effect of Speech Enhancer on speech recognition in children is not yet known and will be evaluated.

NCT ID: NCT05265260 Completed - Clinical trials for Sensorineural Hearing Loss, Bilateral

Factors Affecting Early Progress of Cochlear Implant Outcomes in Adults

PROGRESS
Start date: April 21, 2022
Phase:
Study type: Observational

The aim of this study is to understand how audiometric, cognitive and electrophysiological results relate to sentence recognition score in adults using currently a Nucleus cochlear implant.

NCT ID: NCT05230498 Recruiting - Clinical trials for Sensorineural Hearing Loss, Bilateral

Study of Sound and Speech Perception in New Cochlear Implanted Subjects Using or Not an Anatomy-based Fitting

Start date: February 15, 2022
Phase: N/A
Study type: Interventional

Main objective: Compare the recognition of environmental sounds with an anatomy-based fitting and with a default fitting adult patients newly implanted with a MED-EL cochlear implant. Secondary objectives: Compare speech recognition in quiet with an anatomy-based fitting and with a default fitting in adult patients newly implanted with a MED-EL cochlear implant. Compare speech recognition in noise with an anatomy-based fitting and with a default fitting in adult patients newly implanted with a MED-EL cochlear implant.

NCT ID: NCT05154188 Not yet recruiting - Clinical trials for Sensorineural Hearing Loss, Bilateral

Post Approval Study to Assure the ContInued saFety and effectIveness of Neuro Cochlear Implant System in Adult Users

PACIFIC
Start date: September 1, 2025
Phase:
Study type: Observational

On June 23, 2021, the Oticon Medical Neuro Cochlear Implant System (NCIS) was granted premarket approval (PMA) in the US to treat individuals 18 years or older, with bilateral severe-to-profound sensorineural hearing loss, who obtain limited benefit from appropriately fitted hearing aid(s). To help assure the continued safety and effectiveness of an approved device, a post-approval study was required as a condition of approval under 21 CFR 814.82(a)(2). The purpose of this study is to provide longer-term data on the safety and effectiveness of the Neuro Cochlear Implant System under general conditions of use in the postmarket environment.