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Hearing Loss, Bilateral clinical trials

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NCT ID: NCT03803943 Recruiting - Clinical trials for Hearing Loss, Bilateral

Early Communication Intervention for Toddlers With Hearing Loss

Start date: June 15, 2019
Phase: Phase 2
Study type: Interventional

Improving spoken language outcomes for children with hearing loss has important public health implications. This is a randomized clinical trial of 96 children with hearing loss that examines the effects of a parent-implemented early communication intervention on prelinguistic and spoken language outcomes. The study is open for national recruitment. Parents participate via video call with their child and receive technology to assist with virtual visits.

NCT ID: NCT03694704 Withdrawn - Clinical trials for Sensorineural Hearing Loss, Bilateral

Study of Auditory Performance on Prosodic Tests in Cochlear Implanted Subjects Using a Fine Structure Strategy

Start date: February 28, 2019
Phase: N/A
Study type: Interventional

Main objective: Investigate how the FineHearing strategy of the MED-EL cochlear implant can extract prosody based solely on the frequency of the voice fundamental (F0) in speech Secondary objectives: Evaluate the time evolution of the results of prosodic tests Evaluate the time evolution of the results of differential frequency threshold test Evaluate the time evolution of vocal audiometric tests in silence and noise Evaluate the correlation between prosodic test results and frequency differential threshold results

NCT ID: NCT03674086 Completed - Clinical trials for Hearing Loss, Sensorineural

Evaluation of the eAdjust Application

Start date: August 23, 2018
Phase:
Study type: Observational

Despite being effective, the majority of people who would benefit from using hearing aids do not access them. For those who do obtain hearing aids, around 20% do not wear them regularly. People often do not use their hearing aids because they continue to experience difficulties when listening to and understanding speech in noisy situations. Conventional hearing aids must be programmed and adjusted by a trained audiologist with specialist equipment and therefore provide limited user-control over the hearing aid's functionality. In comparison to conventional hearing aids, Smartphone-connected hearing aids enable patients to adjust their programmes themselves in different situations using a Smartphone application. Smartphone-connectivity can supplement clinical practices, as patients can adjust their hearing aids without the need to visit the clinic. This has the potential to empower patients to be actively involved in their own hearing healthcare. A systematic review assessing the effectiveness of alternative listening devices showed that there is no published high-quality research assessing the clinical effectiveness of Smartphone-connected hearing aids. Furthermore, a usability research study has shown that patients want to personalise and adjust their own HA programmes to meet their individual needs. Having carried out the early development work, the next step would be to carry out a study to evaluate smartphone-connected hearing aids, in accordance with the MRC guidelines on developing and evaluating complex interventions. This study will assess the benefits of a smartphone application, eAdjust that has been developed for use with Phonak Audeo B90-Direct hearing aids. The eAdjust app connects to the hearing aid via Bluetooth, and enables hearing aid users to fine-tune their hearing aids via their smartphone. The benefits of the eAdjust app will be assessed in the real-world as well as in the laboratory. A mixed methods approach will be taken, using both behavioural and patient reported outcomes.

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: NCT03304106 Completed - Cochlear Implant Clinical Trials

Clinical Investigation of New CI Delivery Models in an Adult Nucleus CI Population

Start date: October 19, 2017
Phase: N/A
Study type: Interventional

Use of Artificial Intelligent (AI) technology to assist audiologists in programming cochlear implants.

NCT ID: NCT03287700 Recruiting - Clinical trials for Hearing Loss, Sensorineural

Designing a Trial of Bilateral Cochlear Implantation in Adults

FOUNDATION
Start date: June 14, 2017
Phase:
Study type: Observational

In the UK, cochlear implantation is the standard treatment for adults with 'severe-to-profound' deafness. This level of deafness means that without a cochlear implant they have difficulty understanding what people are saying even when they wear hearing aids. The NHS provides a cochlear implant for one ear even though these adults are deaf in both ears. Two cochlear implants could help them understand speech in noisy environments, know where to look to see who is talking, and avoid hazards outdoors. The decision about who can receive cochlear implants and how many they can receive is based on guidance from the National Institute for Health and Care Excellence (NICE). NICE agreed that providing two cochlear implants can provide additional benefits over providing just one implant. However, they decided that there is not enough evidence to show that these additional benefits are worth the additional cost of providing the second implant. NICE recommended that a clinical trial should be conducted to gather this evidence. This study will consult with patients to explore whether the trial would be acceptable to future implant recipients. The study will also work with clinicians to design a trial comparing bilateral and unilateral implantation in adults. These clinicians will also be surveyed to assess the acceptability of the trial. A group of clinicians that span the range of professions involved in delivering the care pathway will be invited to attend a trial design workshop to establish a consensus on acceptable trial design elements from a clinical perspective. Representatives from cochlear implant manufacturers will be consulted to determine possible strategies for securing industry support for a future trial. Those who run cochlear implantation services will be engaged in a working group to gather information on the current care pathway to inform future assessments of whether bilateral implantation could be cost-effective.

NCT ID: NCT03253003 Completed - Clinical trials for Hearing Loss, Bilateral Sensorineural, Progressive

Quality Control of CE-Certified Phonak Hearing Aids - 2017_27

Start date: August 7, 2017
Phase: N/A
Study type: Interventional

A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted on hard of participants with a hearing loss to grant quality control prior to product launch. The aim of the investigation series is to ensure a stable overall performance of the new hearing systems, a good sound quality during phone calls as well as maximum benefit for the participant with the devices.

NCT ID: NCT03156465 Completed - Child Clinical Trials

Iowa Cochlear Implant Clinical Research Center Hybrid L24 and Standard Cochlear Implants in Profoundly Deaf Infants

Start date: September 15, 2011
Phase: N/A
Study type: Interventional

The purpose of this feasibility study is to evaluate whether implantation of one Nucleus L24 electrode array and one FDA approved standard-length device in the contralateral ear can provide useful binaural hearing in pediatric subjects who have bilateral severe to profound hearing loss, meeting the criteria for cochlear implantation. Unlike a conventional cochlear implant, the Nucleus L24 is expected to preserve the regions of the cochlear partition that are apical to the electrode, thus leaving them available for possible future advances in the field of otolaryngology and hearing devices, such as mammalian hair cell regeneration techniques or improved implantable hearing devices. Whether or not this group of children will be able to take advantage of future hair cell regeneration strategies is yet to be determined and will have to wait for future development. At this time there are no accurate imaging strategies available to identify preservation of the scala media. Ultra thin micro CT scanning is in development, however the level of radiation delivery to the subject is too great to be considered for clinical use. When imaging strategies become available to determine cellular structure of the inner ear, they will be applied to this group of subjects. The Nucleus L24 array stimulates the basal turn of the cochlea, in an attempt to preserve the middle and apical regions of the scala media.

NCT ID: NCT03131557 Completed - Clinical trials for Hearing Loss, Bilateral Sensorineural, Progressive

Quality Control of CE-Certified Phonak Hearing Aids - 2017_13

Start date: June 12, 2017
Phase: N/A
Study type: Interventional

A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted on hard of participants with a hearing loss to grant quality control prior to product launch. The aim of the investigation series is to ensure usability, zero-defect overall performance of the new hearing systems as well as maximum benefit for the participant with the devices in comparison to previously outstanding Phonak Hearing Systems.

NCT ID: NCT03108768 Completed - Clinical trials for Hearing Loss, Bilateral Sensorineural, Progressive

Quality Control of CE-Certified Phonak Hearing Aids - 2016_37

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

A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted on hard of participants with a hearing loss to grant quality control prior to product launch. The aim of the investigation series is to ensure zero-defect overall performance of the new hearing systems as well as maximum benefit for the participant with the devices in comparison to previously outstanding Phonak Hearing Systems.