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Deafness clinical trials

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NCT ID: NCT05488535 Completed - Hearing Loss Clinical Trials

Non-significant Risk Study of a Cochlear Implant Headpiece

Start date: February 28, 2019
Phase:
Study type: Interventional

This study aims to evaluate a cochlear implant headpiece.

NCT ID: NCT05438225 Completed - Hearing Loss Clinical Trials

Text Message Reminders for Hearing Healthcare

Start date: October 17, 2022
Phase: N/A
Study type: Interventional

Many individuals with hearing loss do not receive adequate hearing healthcare. Given their close and long-term relationships with patients, primary care providers (PCPs) could play a vital role in improving access to hearing healthcare. Unfortunately, hearing loss is often underdiagnosed in primary care settings, because hearing screening is not a routine part of primary care visits, and the responsibility often falls on the patient or family to recognize and address the issue. The investigators propose to pilot test the use of text message reminders to encourage elderly patients to discuss hearing assessment with there PCPs. The study objectives are to: 1) design an automated text-messaging reminder system; 2) assess the feasibility of deploying the intervention in a clinical trial setting; and 3) evaluate whether the intervention increases willingness to seek hearing healthcare.

NCT ID: NCT05423548 Completed - Clinical trials for Congenital Sensorineural Hearing Loss

Analysis of Risk Factors of Neurodevelopmental Disorder in Deaf Infants Under Ten Months of Age.

EnTNDre
Start date: August 3, 2022
Phase:
Study type: Observational

Among risk factors of neurodevelopmental disorder is congenital hearing loss. However, congenital deafness is neither necessary nor sufficient for the occurrence of warning signs of neurodevelopmental disorder. The investigative team hypothesizes that the co-occurrence of these two clinical entities results from a common origin, within a syndromic diagnosis including other medical issues. These situations would therefore be very different from those of babies suffering from isolated sensorineural deafness. This study aims to identify which factors are statistically correlated with the association of congenital deafness and early symptoms of neurodevelopmental disorder, thanks to a partnership between a regional center for psychiatry of deaf children (Therapeutic Childhood and Deafness Unit of St Maurice Hospitals, UTES) and a pediatric audiophonology department (ENT department of the Necker-Enfants Malades hospital). This work is based on a cohort of 26 children under ten months of age diagnosed with severe to profound congenital sensorineural hearing loss. As part of their pre-implantation cochlear assessment, a consultation was filmed to precisely analyze the interactional and sensorimotor skills of these children (clinical observations, administration of a specific evaluation grid called Olliac Grid), after reviewing the films. The investigative team will then be able to grade the neurodevelopmental risk. In order to clarify what factors are linked with a neurodevelopmental risk, medical data concerning the child's family context, birth, and audiological profile will also be collected, and put in perspective with the assessed neurodevelopmental risk gradation.

NCT ID: NCT05420038 Completed - Hearing Impairment Clinical Trials

Do Bluetooth Noise Cancelling Headphones Improve the Quality of Care in Hearing Impaired Patients?

Start date: July 6, 2022
Phase:
Study type: Observational

Participants will be recruited by performing chart reviews of patients to be seen at University of Texas Medical Branch at Galveston Ophthalmology and Optometry Clinic. A sample size of at least 30 patients is needed (60 eyes). Patients aged 55 and higher will be further evaluated to meet the inclusion criteria. Patients meeting inclusion criteria will be provided with informed consent to participate in the study before their office visit. Patients will receive a consent briefing then asked to sign and date the informed consent form. Participants will then be randomized to undergo an eye exam and refractive exam with noise cancelling Bluetooth headphones for one eye and without for the other eye. Participants will fill out a written survey asking them to rate the quality of the eye exam with and without headphones. Primary aim: Assess the quality improvement of Ophthalmic exam in geriatric patients with hearing loss with use of noise cancelling headphones with Bluetooth feature. Secondary aims: 1)Compare the response to the standardized questions with and without Bluetooth noise cancelling headphones to determine their effectiveness in conducting Ophthalmic refractive exam. 2) Explore the ease of conducting refractive exam as reported by provider.

NCT ID: NCT05379231 Completed - Unilateral Deafness Clinical Trials

Evaluation of BiCROS Fitting Benefits

Start date: July 11, 2022
Phase: N/A
Study type: Interventional

23 candidates for BiCROS hearing aids will be recruited and fitted with a hearing aid and a CROS device. Following a real-world trial, each participant will be tested on a range of outcome measures including speech recognition in noise, ratings of listening effort, and ratings of preference.

NCT ID: NCT05337748 Completed - Hearing Loss Clinical Trials

Clinical Validation of the Lexie Lumen Hearing Aid

Start date: April 11, 2022
Phase: N/A
Study type: Interventional

More than half a billion people globally have hearing loss. Most hearing loss is sensorineural, meaning that the hearing loss is irreversible and requires rehabilitation. The majority of people with hearing loss have mild to moderate degrees, for which the most effective treatment options are hearing aids. Over the past few years, there have been many developments in hearing technology and the service delivery models in which they are supplied. Traditional hearing care models include several visits to a qualified hearing professional who must both perform diagnostics and prescribe hearing aids, which in the past has been the only way to obtain hearing aids. However, newer developments include forms of self-fitting hearing aids that enable a user to perform threshold measurements to determine the degree of hearing loss and automatically program and fine-tune hearing aids. These devices are now becoming available as direct-to-consumer (DTC) or over-the-counter (OTC) hearing aids. Furthermore, alternative care models have been suggested to bolster access and uptake of assistive technology for hearing loss. Regulations on DTC and OTC hearing aids are starting to come into effect. In 2017, the FDA Reauthorization Act of 2016 directed the FDA to create a category for OTC hearing aids for adults with perceived mild-to-moderate hearing loss. In October 2021, the FDA formally proposed a rule to establish the OTC hearing aid category as part of this process. These changes in regulations would mean that soon, many of these self-fitting devices will become available. In response to these changes in service delivery models, the hearX group recently developed the Lexie Lumen hearing aids that can perform in-situ hearing threshold estimations and automatically prescribe hearing aid gain settings that closely approximate the gold-standard NAL-NL2 fitting prescription. This study aims to evaluate whether the performance of the novel Lexie self-test and self-fitting hearing aid is equivalent to the same hearing aid programmed professionally by an audiologist using a professionally obtained audiogram.

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: NCT05286385 Completed - Clinical trials for Hearing Impairment, Sensorineural

CP1150 Sound Processor Speech Perception Compared With the Next Generation of Signal Processing Technology

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

This clinical study aims to investigate speech performance in quiet with an OTE Sound Processor with modified firmware compared with the commercially available CP1150. The study also investigates CP1110 and CP1150 with Forward Focus.

NCT ID: NCT05280808 Completed - Hearing Loss Clinical Trials

Evaluation of Software for Self-Fitting of Hearing Aids by People With Hearing Loss

Start date: March 18, 2022
Phase: N/A
Study type: Interventional

The purpose of the study is to evaluate the efficacy of a prototype app for the self-fitting of hearing aids.

NCT ID: NCT05190081 Completed - Hearing Loss Clinical Trials

Task Training In Older Adults With Age-Related Hearing Loss

Start date: January 1, 2019
Phase: N/A
Study type: Interventional

This study aimed to examine the effects of single and dual-task training on physical function, cognitive function, quality of life, balance, concerns about falling, and activities of daily living in the elderly with age-related hearing loss. The elderly who were diagnosed with age-related hearing loss in Pamukkale University Health, Practice and Research Center, Department of Otorhinolaryngology participated in the study. The elderly were allocated a single-task training group, dual-task training group, and control group. Thirteen patients in the single-task training group, 15 patients in the dual-task training group, 14 patients in the control group completed the study. Degrees of hearing loss were determined by pure tone audiometry. Evaluations, Senior Fitness Test, Montreal Cognitive Assessment, World Health Organization- Quality of Life- Old Module, Berg Balance Scale, Falls Efficacy Scale International, Functional Independence Measure, Dual Task Questionnaire, Dual Task Effect, were performed initially, after the interventions and at the 6th month. The interventions were carried out two days a week and 40 minutes, for five weeks.