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Hearing Loss, Sensorineural clinical trials

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NCT ID: NCT04222296 Completed - Cochlear Implant Clinical Trials

Bimodal, CROS and Severe Profound Hearing Loss Study

Start date: September 4, 2018
Phase: N/A
Study type: Interventional

The study will involve the comparison of three groups with severe-profound hearing loss. Patients with a Cochlear Implant only, patients with a cochlear implant and Hearing Aid, and finally patients with two hearing aids. This will enable a comparison of standard fitting protocols against the new rationale using the same devices. Devices used for patients in all 3 groups are now available in standard of care, and can be kept afterwards should the patients wish.

NCT ID: NCT04207866 Recruiting - Rehabilitation Clinical Trials

Auditory Training Via Teleconference

Start date: June 2022
Phase: N/A
Study type: Interventional

Multi-channel cochlear implants have been highly successful in restoring speech understanding to individuals with severe-to-profound hearing loss. Optimal programs facilitate access to sound but do not necessarily result in optimal performance. Practiced listening with auditory inputs is required to retrain the brain to hear using a cochlear implant. In some cases exposure to sound in everyday listening is sufficient; however, in others there is a need for the provision of auditory training (AT) by a trained professional. In these cases it is important to have regular visits with a specialist to: 1) facilitate auditory training exercises; 2) work with the family/friends to encourage optimal communication strategies in the home; 3) evaluate and assess achievement of listening goals. This study seeks to evaluate the feasibility of providing auditory training services remotely for patient populations located outside of Toronto. This study also seeks to evaluate interindividual perspectives regarding access and benefits of these services across remote and in person sessions.

NCT ID: NCT04183361 Enrolling by invitation - Clinical trials for Sensorineural Hearing Loss

ABR Characteristics and Salivary Cortisone Concentration in Noise-exposed Workers

Start date: November 1, 2019
Phase:
Study type: Observational

The aim of the research: Investigate the association of auditory evoked brainstem response characteristics with salivary cortisone concentrations in noise-exposed workers. Purpose of the research: 1. Investigate the magnitude of the amplitudes and latencies of auditory brainstem responses. 2. Investigate the concentration of cortisone in saliva. 3. To investigate the correlation of the characteristics of auditory evoked brainstem potentials with the age of the subjects or the length of work in noise. 4. Investigate the association of salivary cortisone concentration with subjects' age or length of work in noise. 5. Investigate the prevalence of mild, moderate and severe hearing impairment in the 19-35 age group. 6. Investigate the relationship of hearing threshold shift with the age of the subjects or the length of work in noise. 7. To investigate the difference in the characteristics of auditory evoked brainstem potentials and the difference in salivary cortisone concentration between subjects with a bilaterally normal hearing threshold (≤25 dB) at high frequencies and subjects with unilaterally or bilaterally increased hearing threshold (> 25 dB) at high frequencies . 8. Investigate the perceived stress and psychosocial risk factors in the workplace and their relationship to salivary cortisone concentrations. Research Hypothesis: There is an association between the characteristics of auditory evoked brainstem response and salivary cortisone concentrations in noise-exposed workers. Research participants Inclusion criteria: 1. male and female 2. ages 19-35 3. exposure to noise level ≥ 85 dB (A) per week at the workplace 4. work in noise from 1 to 16 years 5. workplace not involving exposure to carbon disulfide or a mixture of organic solvents that have toxic effects on the ear (toluene, xylene and styrene) 6. unilaterally or bilaterally normal otoscopic findings 7. unilaterally or bilaterally tympanogram: peak pressure value ± 50 daPa at 226 Hz with eardrum mobility of 0.3 to 1.3 mL Exclusion criteria: 1. information about an earlier sudden hearing loss 2. information on chronic middle ear inflammation 3. information on ear surgery (except placement of ventilation tubes in the eardrum) 4. information on dizziness associated with hearing loss and noise 5. information on insomnia 6. current use of oral corticosteroids 7. bilaterally found air-bone gap greater than 15 dB

NCT ID: NCT04183348 Completed - Hearing Loss Clinical Trials

Evaluation of the Effect of a Visio-Hearing Training Protocol on Spatial Hearing in Subjects With Hearing Loss

EVA
Start date: July 6, 2020
Phase: N/A
Study type: Interventional

We recently developed a new Neuro-immersion system based on virtual reality and 3D (dimension) motion tracking. This tool makes it possible to evaluate and record the spatial localization performance of sounds and to highlight localization deficits in the three dimensions of space in deaf patients. Unfortunately, there is currently no suitable support to compensate for these localization deficits. However, the discomfort felt by the patients is clearly verbalized. Thanks to the new virtual reality system, we are now able to develop a training protocol based on spatial sound localization tasks.

NCT ID: NCT04162405 Recruiting - Hearing Loss Clinical Trials

Tinnitus in Patients With and Without Sensorineural Hearing Loss

Start date: November 1, 2019
Phase:
Study type: Observational

The aim of this study is to evaluate hearing characteristics in patients with and without tinnitus using DPOAE and specific tinnitus severity index (TSI) and tinnitus handicap inventory (THI) questionnaires in both groups. Purpose of the research: Demonstrate that the characteristics of tinnitus depend on the presence and magnitude of hearing loss. Research participants: 150 patients coming for further audiological treatment due to tinnitus. Data will be collected from an electronic database that is filled in during diagnostic processing. During the diagnostic processing, TSI and THI questionnaires will be filled in, a tone audiogram (TA) and DPOAE will be performed.

NCT ID: NCT04161261 Enrolling by invitation - Hearing Loss Clinical Trials

Minimizing Facial Nerve Stimulation in Cochlear Implants

Start date: December 13, 2019
Phase: N/A
Study type: Interventional

This study aims to understand how to manipulate the electrical stimulation from the cochlear implant to maximize hearing stimulation and minimize facial stimulation. It is know from animal data that the hearing and facial nerves have different sensitivities to things like electrical pulse shape, its pattern, and its duration. It is very unclear however if this applies to human cochlear implant patients, and what the optimal parameters are to selectively stimulate the hearing nerve in humans. The outcomes of this study will be used to more selectively program some patients with severe facial nerve cross stimulation and to inform the development of new types of implant stimulation.

NCT ID: NCT04145661 Completed - Clinical trials for Cochlear Hearing Loss

Non-linear Frequency Compared to Conventional Processing in Patients With and Without Cochlear Dead Regions.

Start date: November 20, 2019
Phase: N/A
Study type: Interventional

The investigators are interested in an additional hearing aid feature called non-linear frequency compression (NLFC). This aims to improve audibility of high frequency sounds by converting them into lower frequencies and has been shown to benefit those with moderate-severe sensorineural hearing loss (SNHL). Cochlear dead regions (DRs) are areas of the inner hearing organ (the cochlea) where there is little or no function and are commonly found in regions responsible for detecting high pitched (frequency) sounds. Not all people with hearing loss have DRs. The investigators would like to determine whether based on the presence or absence of DRs, patients with moderate-severe SNHL perform better or prefer their hearing aids programmed conventionally, or with NLFC activated. To do this, two participant groups will be created based on findings from the threshold equalising noise (TEN) test which identifies cochlear DRs. Two participant groups will be created; one group with DRs and one group without DRs. All participants will receive two hearing aids and will wear these programmed conventionally for ~six weeks and with NLFC activated for ~six weeks in a counterbalanced manner. Following each condition, participants will complete a questionnaire and various speech tests will be performed. This involves participants repeating sentences, words or speech sounds they hear from a speaker in quiet and in the presence of background noise. Individuals' scores will be calculated for each test and their performance when NLFC was activated and deactivated will be compared. This will be analysed alongside the questionnaire data to compare the 'DR' and 'no DR' group in both conditions. Findings may help to determine whether NLFC should be activated for all moderate-severe SNHL patients, or just those with DRs, helping clinicians to optimise hearing aid settings for patients.

NCT ID: NCT04131439 Recruiting - Clinical trials for Hearing Loss, Sensorineural

CT and MRI for Pre-Operative Cochlear Imaging

Start date: December 1, 2019
Phase:
Study type: Observational

This study investigates the role of the preoperative computed tomography (CT) and magnetic resonance imaging (MRI) before cochlear implants and their role in selecting suitable patients for surgery.

NCT ID: NCT04130113 Recruiting - Clinical trials for Hearing Loss, Cochlear

Expanded Indications in the MED-EL Pediatric Cochlear Implant Population

Start date: September 18, 2019
Phase: N/A
Study type: Interventional

Sixty (60) subjects between the ages of 7 months and 5 years, 11 months will be implanted with the MED-EL SYNCHRONY/SYNCHRONY 2 Cochlear Implant System. All subjects will demonstrate a severe to profound sensorineural hearing loss (SNHL) in the high frequencies (2000 Hz and above) and insufficient functional access to sound with appropriately fit amplification and aural habilitation. Additionally, subjects implanted under 12 months of age will demonstrate a severe to profound sensorineural hearing loss, defined by a 3-frequency Pure Tone Average (PTA) of ≥ 70 dB HL at 500, 1000 and 2000 Hz, while subjects 12 months to 5 years, 11 months of age will demonstrate a mild to profound sensorineural hearing loss in the low frequencies, defined by a 3-frequency PTA of ≥ 25 dB HL at 500, 1000 and 2000 Hz. For the purposes of this study, insufficient functional access to sound for children who lack the requisite language to complete open-set word recognition testing will be based on the LittlEARS Auditory Questionnaire (LEAQ) and defined as a Total Score below the expected value for normal hearing (NH) children of the same chronological age1. For children with the requisite language to complete MLNT/LNT testing, insufficient functional access to sound will be defined by word recognition scores of ≤ 60% on the MLNT/LNT. Subjects will be followed for twelve (12) months following initial activation of the audio processor, with post-operative evaluations occurring at device.

NCT ID: NCT04129775 Completed - Clinical trials for Sensorineural Hearing Loss

OTO-413 in Subjects With Speech-in-Noise Hearing Impairment

Start date: October 1, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and exploratory efficacy of OTO-413 administered as an intratympanic injection for the treatment of speech-in-noise hearing impairment.