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Hearing Loss, Bilateral clinical trials

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NCT ID: NCT06354010 Not yet recruiting - Clinical trials for Sensorineural Hearing Loss, Bilateral

Cross-sectional and Prospective Study to Characterize Early-onset Presbycusis

SONG
Start date: April 2024
Phase:
Study type: Observational

The purpose of this study is to characterize and assess the evolution of hearing impairment of patients with adulthood-onset bilateral sensorineural hearing loss carrying mutations on GJB2 gene.

NCT ID: NCT06293482 Not yet recruiting - Clinical trials for Hearing Loss, Sensorineural

Safety and Effectiveness of Cochlear Implantation in an Expanded Adult Population

ACE
Start date: May 2024
Phase: N/A
Study type: Interventional

This study aims to evaluate the safety and efficacy of cochlear implantation for adults with bilateral sensorineural hearing loss who currently do not meet the FDA-approved indications for cochlear implantation. Following cochlear implantation, participants will complete speech perception assessments and questionnaires over the course of seven visits.

NCT ID: NCT06176625 Active, not recruiting - Delirium Clinical Trials

Sight and Hearing Investigation Into Effects on Delirium

SHIELD
Start date: January 11, 2023
Phase: N/A
Study type: Interventional

The goal of this observational study is to learn about sensory loss in hospital patients with delirium. The main questions it aims to answer are: - Are hearing and vision loss related to increased risk of having delirium? - Do hearing and vision loss contribute to more severe delirium? - Do sensory loss and/or delirium affect patient satisfaction with hospital care? Participants will be asked to: - answer delirium screening questions, - undergo hearing & vision screenings, and - complete questionnaires about the hospital stay. The second part of this study is a clinical trial. Researchers will compare different hospital units to see if changing communication affects the number of patients with delirium. The main questions it aims to answer are: • Does sharing information about communication and/or providing hearing devices change the number of hospital patients with delirium? Participants in the study will be asked to complete delirium screenings and answer questions about their hearing and communication.

NCT ID: NCT06106373 Recruiting - Clinical trials for Hearing Loss, Sensorineural

iotaSOFT Pediatric Study

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

Prospective, non-randomized, open-label study to evaluate the safety and efficacy of the iotaSOFT Insertion System when used to assist electrode array insertion during cochlear implant surgery in a pediatric population.

NCT ID: NCT06058767 Recruiting - Hearing Loss Clinical Trials

Preschool Hearing Screening

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

Children who are deaf or hard-of-hearing (D/HH) are at risk of speech and language delays, which can be mitigated through early identification and intervention. Identifying hearing loss (HL) during preschool is crucial, but the most effective hearing screening method for preschoolers remains uncertain. The purpose of this study is to learn whether, compared to the gold-standard two-stage Pure-tone audiometry (PTA) + otoacoustic emissions (OAE) screening (TS-PO), single-stage OAE (SS-O) screening alone is not inferior at identifying hearing loss when performed in a community-based preschool setting. This study holds the potential to improve early hearing loss detection and intervention among D/HH children, reducing the likelihood of speech and language delays. A diverse group of 28,000 preschool-age children across community-based preschool centers will be recruited. The intervention involves all subjects undergoing both PTA and OAE screening, with the order determined through randomization. Children who show potential hearing issues based on screening results or teacher concerns will receive further testing to determine the final hearing outcome. Group allocation will be post-hoc, based on their screening results. In addition to the primary objective, the study will compare other hearing screening measures and outcomes between the two methods (TS-PO and SS-O). This approach aims to reflect the real-life effectiveness of hearing screening in a diverse population. Ultimately, the study seeks to provide insights into an optimal hearing screening method that could prevent speech and language delays among D/HH children.

NCT ID: NCT06021132 Recruiting - Clinical trials for Hearing Loss, Sensorineural

Characterisation of Low Frequency Hearing and Vestibular Function in Patients Undergoing Cochlear Implantation

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

The study will follow a cohort of CI-candidates becoming CI-user, till two years postoperative. A through-out assessment of both their audiological and vestibular status will be carried out at multiple fixed timepoints over 2 years, evaluating both subjective (patients reported) and objective outcomes over time. For the audiological part of the study both pure-tone and speech audiometry results will be held against the patient perceived benefit of the treatment as assessed by the questionnaires NCIQ and SSQ-12. The vestibular part of the study will evaluate the function of the SCCs and the sacculus. This is will be put in concert with functional tests of the vestibular system, and the patient perceived outcome measure DHI. Correlations between vestibular and audiological performances will be examined. A collection of specific hypotheses will be tested by predefined statistical methods.

NCT ID: NCT05955469 Recruiting - Clinical trials for Sensorineural Hearing Loss, Bilateral

Comparison in New Cochlear Implanted Subjects of a Tonotopy-based Bimodal Fitting and a Conventional Fitting

Start date: October 15, 2023
Phase: N/A
Study type: Interventional

Main objective: For a bimodal fitting (hearing aid (HA) + cochlear implant (CI)): Comparison of a tonotopy based fitting strategy (TFS4) to a default fitting strategy (FS4) for the speech recognition in noise. Secondary objectives: Comparison of TFS4 to FS4 for speech recognition in quiet. Comparison of TFS4 to FS4 for the auditory skills experienced by the subject.

NCT ID: NCT05898659 Recruiting - Clinical trials for Sensorineural Hearing Loss, Bilateral

Comparison in New Cochlear Implanted Subjects of a Tonotopy-based Bimodal Fitting With or Without Synchronization

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

Main objective: For a bimodal fitting (hearing aid (HA) + cochlear implant (CI)): Comparison of a tonotopy based fitting strategy with synchronization between HA and CI (ABFS) to a tonotopy based fitting strategy without synchronization (ABFnoS) for the accuracy of sound localization. Secondary objectives: Comparison of ABFS to ABFnoS for the bias of sound localization. Comparison of ABFS to ABFnoS for speech perception in noise. Comparison of ABFS to ABFnoS for the auditory skills experienced by the subject.

NCT ID: NCT05855005 Active, not recruiting - Hearing Loss Clinical Trials

Direct-to-Consumer Hearing Aids and Listening Effort

Start date: October 25, 2022
Phase: N/A
Study type: Interventional

The aim of this proposed project is to understand whether direct to consumer (DTC) hearing aids programmed to individual hearing losses, can reduce listening effort for effective communication. If DTC aids can provide benefits beyond amplification, then they could be an affordable option to reduce barriers to care and improve hearing aid uptake in adults with hearing loss.

NCT ID: NCT05828017 Completed - Clinical trials for Hearing Loss, Sensorineural

Investigating Hearing Aid Frequency Response Curves 2

Start date: May 1, 2023
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. Based on the conclusions of the first study, we have identified areas that require further analysis and testing prior to implementing of the proposed frequency response curve into our products. 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.