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Deafness clinical trials

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NCT ID: NCT05782153 Completed - Hearing Loss Clinical Trials

Comparing Self-Fitting Strategies in the Lexie Powered by Bose Hearing Aids

Start date: July 17, 2023
Phase: N/A
Study type: Interventional

More than 1.5 billion people around the world experience hearing loss, of whom at least 430 million experience disabling hearing loss that will require rehabilitation. The majority of people have mild to moderate hearing loss and can benefit from hearing aids. However, hearing aid adoption around the world has been low, with global hearing aid coverage being less than 11%. This is partly due to limited access to hearing healthcare services and the high cost of hearing devices. However, there have been significant efforts to improve access to hearing healthcare services. This includes rapid advances in hearing aids and new service-delivery models leading to more affordable and accessible options such as Over-the-Counter (OTC) hearing aids. On the 17th of October 2022, the Food and Drug Administration (FDA) established a regulatory category for OTC hearing aids. The final rule allows consumers with perceived mild to moderate hearing impairment to purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription or a fitting by an audiologist. The FDA defined two sub-categories for OTC hearing aids, namely 1) OTC hearing aids with standardized output profiles (i.e., pre-set programs) and 2) self-fitting OTC hearing aids which allow users to program their hearing aids with a self-fitting strategy and also customize their hearing aid settings according to their needs and preferences. Sabin et al. (2020) was the first study to validate a self-fitting method using the Bose prototype hearing aid. This self-fitting method allowed users to select their own signal processing parameters using a mobile application consisting of two wheels that simultaneously control the gain and compression of all frequency bands. Sabin et al. (2020) evaluated the real-world performance of this approach by comparing gain, sound quality and clinical measures of hearing aid benefit and satisfaction between a group using the self-fitting method and a group that was professionally fitted with the same hearing aid. The gain selected by the self-fit group was within 1.8 dB overall and 5.6 dB per band compared to the gain selected by the audiologist. Participants in the self-fit group reported better sound quality, and there were no differences in clinical measures of hearing aid benefit or satisfaction. Although a number of studies have compared self-fitting OTC devices to conventional hearing aids fitted by hearing healthcare professionals, no study has compared different self-fitting strategies in the same OTC device. Therefore, this study aims to compare the existing self-fitting strategy of the Lexie Powered by Bose hearing aids (i.e., direct adjustment) to a recently validated in-situ audiometry fitting strategy. The in-situ audiometry fitting strategy consists of in-situ thresholds measurements conducted at 500, 1000, 2000 and 4000 Hz through the hearing aids, which will be used with a proprietary fitting algorithm that is based on National Acoustics Laboratories' Non-Linear Version 2 (NAL-NL2) to self-program the hearing aids.

NCT ID: NCT05681078 Completed - Hearing Loss Clinical Trials

The Impact of Hearing Loss Severity on Balance Intervention Outcomes

Start date: February 8, 2023
Phase: N/A
Study type: Interventional

The goal of this study is to learn about how hearing loss impacts balance intervention outcomes and risk of falling in older adults. The main questions it aims to answer are: - How does the evidence-based A Matter of Balance (AMOB) program affect older adults' falls risk and balance-related measures? - Is the severity of someone's hearing loss related to their balance intervention (AMOB) outcomes? Participants will: - Complete a hearing and balance test - Answer some questions about their background and health history, their thoughts about potential falls and how this impacts them, and their current physical activity level - Participate in the A Matter of Balance Program, an evidence-based program that includes group discussion, activities, and exercises to reduce fall risk

NCT ID: NCT05661487 Completed - Clinical trials for Vertigo Labyrinthine

Correlation MRI - Paraclinical Examination in Sudden Deafness Associated With Vertigo

SBAV
Start date: May 19, 2021
Phase:
Study type: Observational

Acute cochleo-vestibular syndrome or labyrinthitis is characterized clinically by the sudden appearance of a great rotatory vertigo and a unilateral sensorineural hearing loss. In this clinical context, MRI is the examination to eliminate differential diagnoses and to make a positive diagnosis of labyrinthitis (supposedly infectious, immunologic or ischemic). The etiologies described are ischemic, infectious or autoimmune, so the risk factors are very variable (cardiovascular, autoimmune or infectious). Labyrinthitis has been little studied as a clinical entity in its own right. Indeed, studies mainly focus on sudden deafness with subgroups of patients with vertigo. The incidence of sudden deafness is of the order of 5 to 20 per 100,000 people per year but is probably under-diagnosed. The individual and medico-economic consequences are similar to those of hearing loss, with an increased risk of dementia, depression, premature death and an increase in health care consumption.

NCT ID: NCT05656313 Completed - Clinical trials for Hearing Loss, Bilateral

PRINCE22 System Complete Performance Study

Start date: November 3, 2022
Phase: N/A
Study type: Interventional

The investigation proposes to compare a narrow reference beamformer to a novel beamformer approach, when the talker is not in front of the hearing aid user and in the presence of background noise. The beamformer effect will be determined in terms of speech intelligibility, listening effort and ability to multitask when the talkers are located on the side or in the back.

NCT ID: NCT05619575 Completed - Hearing Impairment Clinical Trials

Acceptance and Performance of the CP1170 Sound Processor in Experienced Adult Cochlear Implant Recipients (POLAR)

POLAR
Start date: December 20, 2022
Phase: N/A
Study type: Interventional

Acceptance and performance of the CP1170 sound processor in experienced adult cochlear implant recipients compared with the CP1150 sound processor and their current sound processor.

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: 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.