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Hearing Loss, Bilateral clinical trials

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NCT ID: NCT04469946 Completed - Hearing Impairment Clinical Trials

Hearing Aid Noise Reduction in Pediatric Users Pilot Study (Oticon Pilot Study)

Start date: March 5, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the efficacy of OpenSound Navigator (OSN), a hearing aid speech-enhancement algorithm developed by Oticon, as treatment for pediatric hearing aid users. The study used a within-subjects design with pre- and post-comparisons involving fifteen pediatric (ages 6-12) patients with symmetrical sensorineural hearing losses ranging from the mild to moderately-severe degree. All participants were fit with bilateral Oticon OPN™ behind-the-ear hearing aids set with the OSN algorithm enabled. The investigators evaluated hearing aid benefit through word recognition in noise (behavioral testing) and everyday hearing/listening abilities (parental/legal guardian reported) within one week of the hearing aid fitting (pre-intervention) and two months post fitting (post-intervention).

NCT ID: NCT04427033 Completed - Hearing Loss Clinical Trials

The BCI 602 BONEBRIDGE Post-Market Clinical Follow-up Study

Start date: December 6, 2019
Phase:
Study type: Observational

The Bonebridge system using the BCI 601 is marketed since 2012. Previous prospective, multi-center, non-randomized studies on the BCI 601 Bonebridge performed in adult and paediatric populations have shown a significant improvement in terms of aided sound field (SF) thresholds, word recognition scores (WRS), speech reception thresholds (SRT) and subjective device satisfaction. Safety was established by stable residual hearing and low complication rates. The Bonebridge, implanted in over 600 clinics worldwide, is the world's first active transcutaneous bone conduction implant (BCI) system. This study now focuses on the further developed BCI 602 (marketed since 2019) that has the same indication criteria and performance characteristics. The aim of this post-market clinical follow-up (PMCF) study is to provide clinical data for the long-term performance and safety when implanted with the Bonebridge BCI 602 .

NCT ID: NCT04242940 Terminated - Clinical trials for Bilateral Hearing Loss

Assessing Listening Effort at Different Signal-to-noise Ratios in Bone-anchored Users

Start date: February 21, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to assess listening effort during a speech-in-noise task in bone-anchored hearing systems (BAHS) users via pupillometry.

NCT ID: NCT04226456 Terminated - Tinnitus Clinical Trials

Intratympanic Administration of N-acetylcysteine for Protection of Cisplatin-induced Ototoxicity

Start date: July 10, 2021
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess the efficacity of N-acetylcystein against Cisplatin-induced ototoxicity.

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: 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: NCT04006132 Completed - Clinical trials for Bilateral Hearing Loss

Evaluation of the Benefits of Bilateral Fitting in BAHS Users

Start date: July 4, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the benefit of bilateral implantation with bone-anchored hearing systems (BAHS), in terms of sound localization abilities, as well as auditory working memory. The hypothesis is that the use of two BAHS (bilateral condition) will not only improve localization abilities, but it will also increase the ability to retain words in working memory, compared to performance with only one BAHS (unilateral condition).

NCT ID: NCT03993899 Completed - Clinical trials for Sensorineural Hearing Loss, Bilateral

Study of Quality Perception on Music in New Cochlear Implanted Subjects Using or Not a Fine Structure Strategy

Start date: July 1, 2019
Phase: N/A
Study type: Interventional

Main objective: Show the superiority of Fine Structure (FS4) strategy compared to Continuous Interleaved Sampling (HDCIS) strategy on the qualitative preference for the listening of musical pieces. Secondary objectives - Show the superiority of FS4 strategy compared to the HDCIS strategy on the perception of musical elements (contour test). - Analyze the link between the results of musical perception tests and the subjective preference of musical listening. - Show the non inferiority of FS4 strategy compared to the HDCIS strategy on the perception of speech elements. - Analyze the link between the results of musical perception tests and the results of the perception of speech elements. - Analyze the qualitative multidimensional perception with HDCIS and FS4

NCT ID: NCT03904420 Terminated - Clinical trials for Sensorineural Hearing Loss, Bilateral

An Evidence Based Delivery Model of Care for Newly Implanted Adult CI Recipients

Start date: February 26, 2019
Phase: N/A
Study type: Interventional

The clinical investigation is evaluating a new clinical model in a group of newly implanted subjects who have already been consented to CI surgery.

NCT ID: NCT03861442 Completed - Hearing Loss Clinical Trials

Front-End Processing 3.0

FEP3
Start date: April 1, 2019
Phase:
Study type: Observational

This study investigated the impact of Automatic Sound Management 3.0 (i.e. ambient noise reduction, transient noise reduction and an adaptive intelligence) as implemented in the SONNET2 on CI users' speech performance and their subjective quality of hearing and device handling.