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Hearing Loss clinical trials

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NCT ID: NCT05154539 Completed - Hearing Loss Clinical Trials

Innovation of Hearing Rehabilitation and Effects of Reform

InHEAR
Start date: March 16, 2021
Phase: N/A
Study type: Interventional

The Danish health care system has been criticized for its structural inefficiency and latency to initiate proper hearing rehabilitation amongst hearing-impaired individuals. Waiting lists are extensive, and audiometries are repeated before hearing aid treatment is initiated. Demographic changes forecast increasing numbers of +65-year-olds and consequently increased demand for hearing rehabilitation. To remedy this situation, the Danish Ministry of Health has proposed a new national initiative to implement innovative digital approaches to improve hearing rehabilitation, including a new, digital remote assessment routine. The aim of this study is to investigate: Primarily: 1. Patient safety of remote vs. conventional assessment 2. Patient-reported satisfaction and treatment effect of remote vs. conventional assessment Secondarily: 3. Inter-subspecialty and inter-personal assessment differences between four ENT specialists using a remote assessment routine 4. Translation and validation of the Danish adapted version of the Consumer Ear Disease Risk Assessment (CEDRA) questionnaire. The main study is a randomized clinical trial with three arms and 1:1:1 assignment comprising 751 potential first-time adult hearing aid users. Since March 2021, 751 patients have been randomized and assigned to 20 different clinics. The remote assessment routine works well for both patients, assessors, and clinics. Inclusion is expected to end in December 2021 and overall study completion is anticipated in april 2022. Deficient diagnosis of complicating conditions in first time hearing aid users is the main concern in remote assessment. If the study shows the practice to be safe, it could form the foundation of a future nationwide implementation of remote care in Danish hearing rehabilitation.

NCT ID: NCT05150964 Completed - Hearing Loss Clinical Trials

Measuring Comfort and Clarity With Low Gain Feature in Pediatric Hearing Aid Users

Start date: June 1, 2021
Phase: N/A
Study type: Interventional

Comfort and clarity of speech will be measured in hearing impaired children age 8-17 using standard speech processing algorithm with a soft speech enhancer feature, referred to as the Adaptive Situational Gain (ASG) feature in study documents.

NCT ID: NCT05125601 Completed - Deafness Clinical Trials

PEACH Questionnaire Study

QaPEACH
Start date: December 7, 2021
Phase:
Study type: Observational

There are few or no questionnaires in French on the hearing quality of life of children with hearing aids. The objectives of the study are to measure the hearing quality of life of children with hearing aid and / or cochlear implants and to compare the hearing quality of life according to the type of hearing aid (hearing aid and / or cochlear implant).

NCT ID: NCT05112354 Completed - Clinical trials for Idiopathic Sudden SNHL

Predictive Factors for Recovery in Idiopathic Sensory Neural Hearing Loss

Start date: December 1, 2019
Phase: Phase 2
Study type: Interventional

Sudden sensorineural hearing loss (SSNHL) is an otological emergency that is defined as a hearing loss greater than 30 dB over three consecutive frequencies within 72 hours, with abnormalities of the cochlea, auditory nerve, or central auditory system.1 During 2006 and 2007, the annual incidence of SSNHL was 5-27/100,000 persons per year in the United states.2,3 The causative etiologies for SSNHL included viruses, microcirculation abnormalities, and autoimmune disorders. However, definitive evidence remains elusive.4,5 Currently, steroids are the treatment of choice due to their effects on the inner ear such as immunosuppression and circular enhancement.6,7 Combined systemic and intra-tympanic steroid treatment has previously been reported to be beneficial for SSNHL patients, with overall better treatment outcomes.8,9 However, due to the heterogeneous pathological nature and spontaneous recovery potential of the disease, few controlled studies exist in the literature. As a result, the treatment strategies of SSNHL remain a controversial issue in clinicalpractice .10 The condition exhibits a wide age distribution , with an average of 50-60 years and no sex preference. The hearing loss is unilateral in most Population studies of sudden sensorineural hearing loss cases, with bilateral involvement reported in less than 5%. 11 The severity of the hearing loss is divided roughly equally into mild, moderate, and severe profound. The configuration of the hearing loss varies and can affect high, low, or all frequencies. Tinnitus occurs in about 80% of patients, and vertigo, indicating an associated peripheral vestibular dysfunction, in about 30%. 12 The response to medical therapy shows inconsistent results regarding symptoms especially hearing loss may be due to the uncertainty about the cause of the disease and its progress. little is known about the factors which may contribute to either success or failure of the medical therapy. Aim of work 1. To evaluate the factors contributing to the success or failure of standardized medical therapy in cases of ISSNHL 2. To detect the degree of correlation of the presenting symptoms and comorbidities to the patient final hearing prognosis.

NCT ID: NCT05101083 Completed - Hearing Loss Clinical Trials

Speech Intelligibility in Quiet and Noise for New vs. Legacy Hearing Aids

Start date: October 25, 2021
Phase: N/A
Study type: Interventional

This clinical investigation is designed to compare audiological performance (i.e., measurements of sound quality and speech understanding) between Starkey's new receiver-in-canal device and a commercially available legacy receiver-in-canal device.

NCT ID: NCT05099146 Completed - Hearing Loss Clinical Trials

Impact of Oral Health Education on Oral Hygiene Status of Deaf Children

Start date: October 5, 2019
Phase: N/A
Study type: Interventional

Objective: To compare the impact of pictorial and video demonstration oral health educational interventions on oral hygiene status of children aged 12-16 years with hearing impairment. Methods: This randomized controlled trial spanned over the period of three months was conducted in purposively selected three schools of deaf children of Karachi. Baseline dental examination was performed to assess the dental plaque and gingival status of study participants. Dental plaque and gingival status of the participants was assessed by employing the World Health Organization recommended Plaque Index and Gingival Index. The 60 children were than randomly allocated into three interventional groups, pictorial, video and control, 20 in each group. The children were examined again after one month of oral health education provision by single examiner. Tooth brushes were provided to students at the time of baseline examination to use for one month. Collected data was subjected to statistical analysis and described in terms of Mean and Standard Deviation, mixed model ANNOVA was applied to see the difference between the mean plaque and gingival scores of three groups after one month. The p-value of <0.05 was considered as statistically significant at the 95% confidence interval.

NCT ID: NCT05086809 Completed - Hearing Loss Clinical Trials

Investigation of an Updated Bone-anchored Sound Processor

Start date: September 30, 2021
Phase: N/A
Study type: Interventional

The study is a prospective, single-center, comparative, cross-over study with within-subject control design. In the investigation an updated sound processor will be tested at compared to the CE marked Ponto 3 SuperPower sound processor (available on the market since December 2016) in order to establish marketing claim(s) on the updated sound processor. The performance of the two sound processors will be evaluated via speech and hearing tests, and patient reported outcomes.

NCT ID: NCT05086276 Completed - Clinical trials for Hearing Loss, Sensorineural

FX-322 in Adults With Acquired Sensorineural Hearing Loss

Start date: October 12, 2021
Phase: Phase 2
Study type: Interventional

This is a Phase 2, prospective, randomized, double-blind, placebo-controlled, single-dose, multicenter study to evaluate the efficacy of FX-322, administered by intratympanic injection, in adults with acquired sensorineural hearing loss (SNHL).

NCT ID: NCT05076045 Completed - Clinical trials for Hearing Loss, Age-Related

Effects of PSAPs on Speech Processing

Start date: March 1, 2022
Phase: N/A
Study type: Interventional

Mild to moderate hearing loss remains undertreated, largely because of the high cost of hearing aids. A promising and much less expensive alternative is the use of personal sound amplification products (PSAPs), which are electronic, portable, over-the-counter devices that amplify sound. Studies have shown that the use of PSAPs provides significant hearing benefits and improves the quality of life for older adults with mild to moderate hearing loss. However, there is insufficient data to determine the impact of PSAPs use on speech processing in the brain. The purpose of this study is to use electroencephalography (EEG) measurements to assess the neurobiological and behavioral effects of PSAPs on speech perception in noise in individuals with mild to moderate hearing loss. The investigators expect that the PSAPs use will result in an immediate improvement in the ability to perceive speech-in-noise, supporting that these hearing devices may be a means of restoring communication skills in people with mild to moderate hearing loss. Behavioral benefits will be associated with increased brain activity in auditory regions and connectivity between auditory and speech regions in the brain.

NCT ID: NCT05073796 Completed - Deafness, Bilateral Clinical Trials

Cochlear Implant Electrostimulation and the Influence on the Vestibular Organ

Start date: September 9, 2020
Phase: N/A
Study type: Interventional

There is evidence that the sensor function of the utricle in patients with bilateral labyrinthine dysfunction (bilateral vestibulopathy) may improve balance under the influence of high frequency basal stimulation of the cochlea. The aim of the study is to measure the possible co-stimulation of the utricle (which is determined by the SVV) by tonotopic (frequency-specific) cochlear stimulation and thus to objectify whether the stimulation of the auditory nerve in CI patients also leads to an unavoidable co-stimulation of the vestibular system.