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"Hearing Loss - complications"
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Combination of Electroacupuncture and Medication for Patients With Tinnitus Associated With Idiopathic Sudden Sensorineural Hearing Loss: Protocol for a Prospective Randomized Controlled Trial
2025
Tinnitus, a common and troublesome symptom of idiopathic sudden sensorineural hearing loss (ISSNHL), is the perception of sound without any external or internal sound source. The etiology of ISSNHL accompanied by tinnitus remains unclear. Tinnitus often occurs alongside or before hearing loss and can severely impact patients' quality of life, leading to psychological stress and emotional distress. Current treatments primarily focus on improving hearing loss while neglecting tinnitus treatment. Electroacupuncture (EA), a technique widely applied in China for tinnitus management, may become a promising intervention by addressing both auditory and psychological symptoms.
This study aims to conduct a double-center, assessor-blinded, prospective randomized pilot clinical trial to explore the potential effects and feasibility of EA combined with medication for patients with ISSNHL accompanied by tinnitus, and to generate preliminary data to inform future large-scale trials of EA as an adjunctive therapy for this condition.
In this double-center, assessor-blinded, randomized controlled trial, 60 patients with ISSNHL accompanied by tinnitus will be randomly allocated to either the EA group, receiving EA combined with medication, or the control group, receiving standard medication treatment, for a total treatment duration of 4 weeks. Follow-up assessments will be conducted at weeks 2 and 4, and at 1, 2, and 3 months after treatment. The feasibility primary outcomes are recruitment rate, adherence rate, data completeness, and safety outcomes. The primary outcome measures will include pure tone audiometry, tinnitus matching, and the Tinnitus Handicap Inventory, while the secondary outcome measures will comprise speech-recognition thresholds in noise, the Self-Rating Anxiety Scale, and the 36-item Short Form Health Survey Questionnaire.
This study began recruitment on July 15, 2024, and is scheduled to conclude on August 31, 2025. To date, 42 participants have been enrolled, with 35 having completed the intervention and posttreatment assessments (control group: n=21; EA group: n=14). Following protocol publication, data compilation and analysis will be conducted, with results anticipated to be published in a relevant journal in 2026.
This pilot trial is expected to provide critical insights into the feasibility of integrating EA with standard medication for managing ISSNHL with tinnitus. By generating preliminary evidence on its practicality and potential benefits, this study aims to inform the design and sample size estimation of future multicenter trials, potentially advancing nonpharmacological treatment options for this challenging condition.
Chinese Clinical Trial Registry ChiCTR2400086802; https://tinyurl.com/mtxthpzj.
DERR1-10.2196/69163.
Journal Article
Cognitive benefits of hearing intervention vary by risk of cognitive decline: A secondary analysis of the ACHIEVE trial
2025
INTRODUCTION Results from the Aging and Cognitive Health Evaluation in Elders (ACHIEVE) trial suggest hearing intervention may not reduce 3‐year cognitive decline in all older adults with hearing loss but may be beneficial in certain groups. This secondary analysis investigated if participants with multiple risk factors for cognitive decline received greater benefits. METHODS We used a sample of dementia‐free participants (N = 2692) from the Atherosclerosis Risk in Communities (ARIC) cohort to develop a predictive model for cognitive decline. The model was applied to baseline measures of ACHIEVE participants (N = 977) to estimate predicted risk. We tested an interaction between predicted risk and randomization to hearing intervention or health education control. RESULTS Among ACHIEVE participants in the top quartile of predicted risk, 3‐year cognitive decline in the hearing intervention was 61.6% (95% confidence interval [CI]: 33.7%–94.1%) slower than the control. DISCUSSION The effect of hearing intervention on reducing 3‐year cognitive decline was greatest among individuals with multiple baseline risk factors associated with faster cognitive decline. Trial Registration: ClinicalTrials.gov Identifier: NCT03243422 Highlights The Aging and Cognitive Health Evaluation in Elders (ACHIEVE) trial tested the effect of hearing intervention on cognitive decline. Participants were recruited from the Atherosclerosis Risk in Communities (ARIC) cohort or de novo from the local community. A 48% reduction in cognitive decline was observed in ARIC cohort participants. In this secondary analysis, there was an interaction between hearing intervention and predicted risk of cognitive decline. Among participants in the top quartile of predicted risk of cognitive decline, hearing intervention slowed cognitive decline by 62%.
Journal Article
Performance of hybrid gain formula versus traditional fitting formulas in hearing aid fitting in tinnitus patients with hearing loss
2024
Purpose
Hearing aid fitting can be challenging when tinnitus accompanies hearing loss, as speech intelligibility and quality of life are affected by both hearing loss and tinnitus perception. However, studies focusing on the optimal hearing aid fitting for this group are scarce. Here, we aim to investigate the performance of alternative hearing aid fitting scenarios in improving hearing aid benefit and managing tinnitus.
Methods
Sixty-six participants were included in the study and randomly divided into three groups based on the fitting formula: NAL-NL2, DSL pediatric and hybrid gain fitting procedure (covering NAL-NL2 for low frequencies and DSL pediatric formulas for high frequencies). Hearing aid benefit was evaluated using the Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire and speech perception in noise (SPIN). To evaluate tinnitus perception, psychoacoustic characteristics of tinnitus were determined, and the Tinnitus Handicap Inventory (THI) was gathered.
Results
The NAL-NL2 fitting procedure showed better results in hearing aid benefit and SPIN compared to the DSL pediatric procedure. In the DSL pediatric procedure, better results were obtained in tinnitus management compared to NAL-NL2. There was no difference between the hybrid fitting procedure and DSL pediatric in tinnitus management. The hybrid fitting procedure also did not differ from NAL-NL2 in SPIN and hearing aid benefit.
Conclusion
Here, we propose a hybrid gain fitting procedure that can be a better alternative to boost hearing aid performance and tinnitus management in clinical practice.
Journal Article
Cochlear Implants as a Treatment Option for Unilateral Hearing Loss, Severe Tinnitus and Hyperacusis
by
Falcón González, Juan Carlos
,
Coudert-Koall, Chrystellel
,
García-Ibáñez, Luis
in
Adult
,
Aged
,
Cochlear Implantation
2015
Tinnitus is an incapacitating condition commonly affecting cochlear implant (CI) candidates. The aim of this clinical study is to assess the long-term effects of CI treatment in patients with severe-to-profound, sensorineural, unilateral hearing loss (UHL) and incapacitating tinnitus. We performed a prospective Cochlear™ company-sponsored multicentre study in five Spanish centres. Sixteen patients with UHL and incapacitating tinnitus, which was indicated by a Tinnitus Handicap Inventory (THI) score >58%, received a Nucleus® CI in their deaf ear. The study design includes repeated within-subject measures on hearing, tinnitus, hyperacusis and quality of life up to 12 months after initial CI fitting. In addition to hearing loss and tinnitus, all patients suffered from hyperacusis. Most patients had a sudden hearing loss and received a CI within 2 years after their hearing loss. Preliminary 6-month, post-CI activation data of 13 subjects showed that the majority of patients perceived a subjective benefit from CI treatment, which was assessed using the THI, a Visual Analogue Scale of tinnitus loudness/annoyance and the Speech, Spatial and Qualities of Hearing Scale. Preliminary 12-month data of 7 subjects showed that most patients also perceived a degree of relief from their hyperacusis. One patient showed no improvements in any of the applied scales, which could be explained by partial insertion of the electrode due to obstruction of the cochlea by otosclerosis. In conclusion, CI can successfully be used in the treatment of UHL patients with accompanying severe tinnitus and hyperacusis. Implantation resulted in hearing benefits and a durable relief from tinnitus and hyperacusis in the majority of patients. These findings support the hypothesis that pathophysiological mechanisms after peripheral sensorineural hearing loss are at least partly reversible when hearing is restored with a CI.
Journal Article
Hearing loss and intellectual outcome in children treated for embryonal brain tumors: Implications for young children treated with radiation sparing approaches
by
Dahl, Christine
,
Mabbott, Donald J.
,
Tabori, Uri
in
Adolescent
,
Antineoplastic Agents - adverse effects
,
Audiology
2021
Purpose We investigate the impact of severe sensorineural hearing loss (SNHL) and for the first time evaluate the effect of unilateral versus bilateral SNHL on intellectual outcome in a cohort of children with embryonal brain tumors treated with and without radiation. Methods Data were from 94 childhood survivors of posterior fossa (PF) embryonal brain tumors who were treated with either: (1) chemotherapy alone (n = 16, 7.11 [3.41] years, 11M/5F), (2) standard‐dose craniospinal irradiation (CSI) and/or large boost volumes (n = 44, 13.05 [3.26] years, 29M/15F), or (3) reduced‐dose CSI with a boost restricted to the tumor bed (n = 34, 11.07 [3.80] years, 19M/15F). We compared intellectual outcome between children who: (1) did and did not develop SNHL and (2) developed unilateral versus bilateral SNHL. A Chang grade of ≥2b that required the use of a hearing aid was considered severe SNHL. Comparisons were made overall and within each treatment group separately. Results Patients who developed SNHL had lower full scale IQ (p = 0.007), verbal comprehension (p = 0.003), and working memory (p = 0.02) than patients without SNHL. No differences were observed between patients who had unilateral versus bilateral SNHL (all p > 0.05). Patients treated with chemotherapy alone who developed SNHL had lower mean working memory (p = 0.03) than patients who did not develop SNHL. Among patients treated with CSI, no IQ indices differed between those with and without SNHL (all p > 0.05). Conclusions Children treated for embryonal brain tumors who develop severe SNHL have lower intellectual outcome than patients with preserved hearing: this association is especially profound in young children treated with radiation sparing approaches. We also demonstrate that intellectual outcome is similarly impaired in patients who develop unilateral versus bilateral SNHL. These findings suggest that early intervention to preserve hearing is critical.
Journal Article
First report of quality of life in adults with neurofibromatosis 2 who are deafened or have significant hearing loss: results of a live-video randomized control trial
by
Plotkin, Scott R.
,
Mace, Ryan A.
,
Jordan, Justin T.
in
Activities of Daily Living
,
Adult
,
Aged
2019
Purpose
To test the feasibility, acceptability, and preliminary efficacy of a mind–body program for patients with neurofibromatosis 2 (NF2) who are deaf or have significant hearing loss (d3RP-NF2) against an attention placebo control (dHEP-NF2) in a single-blind randomized control trial. Both were delivered using Communication Access Real-Time Translation and live group videoconferencing.
Methods
Forty-five adults with NF2 were randomized. Co-primary outcomes were physical quality of life (QoL) and psychological QoL and secondary outcomes were social QoL and environmental QoL, all measured with the World Health Organization Quality of Life Abbreviated Instrument (WHOQOL-BREF). Assessments were conducted at baseline, post-treatment, and six-month follow-up.
Results
Forty-one participants (91%) completed the intervention, and 29 (64%) completed the six-month follow up. Participants in the d3RP-NF2 showed significantly greater improvements from baseline to post-treatment on physical QoL (14.79, 95% CI 5.41–24.18;
p
≤ 0.001), psychological QoL (18.77, 95% CI 7.09–30.44,
p
≤ 0.001), and environmental QoL (13.25, 95% CI 1.10–25.39,
p
= 0.03) compared to the dHEP-NF2. Social QoL also significantly increased in the d3RP-NF2 (16.32, 95% CI 6.66–25.97,
p
= 0.001), but improvement was not beyond the dHEP-NF2. Gains in QoL were clinically meaningful and maintained at the 6-month follow-up for d3RP-NF2 participants across all QoL domains. There were more treatment responders in the d3RP-NF2 compared to the dHEP-NF2.
Conclusions
The d3RP-NF2 was well accepted, highly feasible, and resulted in sustained improvements in QoL in patients with NF2 who are deaf or have significant hearing loss.
Journal Article
Problems identified by dual sensory impaired older adults in long-term care when using a self-management program: A qualitative study
by
Vernooij-Dassen, Myrra
,
Roets-Merken, Lieve
,
Hermsen, Pieter
in
Adults
,
Aged, 80 and over
,
Autonomy
2017
To gain insights into the problems of dual sensory impaired older adults in long-term care. Insights into these problems are essential for developing adequate policies which address the needs of the increasing population of dual sensory impaired older adults in long-term care.
A qualitative study was conducted in parallel with a cluster randomized controlled trial. Dual sensory impaired older adults in the intervention group (n = 47, age range 82-98) were invited by a familiar nurse to identify the problems they wanted to address. Data were taken from the semi-structured intervention diaries in which nurses noted the older adults' verbal responses during a five-month intervention period in 17 long-term care homes across the Netherlands. The data were analyzed using descriptive statistics and qualitative content analysis based on the Grounded Theory.
The 47 dual sensory impaired older adults identified a total of 122 problems. Qualitative content analysis showed that the older adults encountered participation problems and problems controlling what happens in their personal environment. Three categories of participation problems emerged: (1) existential concerns of not belonging or not being able to connect with other people, (2) lack of access to communication, information and mobility, and (3) the desire to be actively involved in care delivery. Two categories of control-in-personal-space problems emerged: (1) lack of control of their own physical belongings, and (2) lack of control regarding the behavior of nurses providing daily care in their personal environment.
The invasive problems identified indicate that dual sensory impaired older adults experience great existential pressures on their lives. Long-term care providers need to develop and implement policies that identify and address these problems, and be aware of adverse consequences of usual care, in order to improve dual sensory impaired residents' autonomy and quality of life.
Journal Article
When transcripts matter: delineating between non-syndromic hearing loss DFNB32 and hearing impairment infertile male syndrome (HIIMS)
by
Ardalani Fariba
,
Najmabadi Hossein
,
Nikzat Nooshin
in
Auditory system
,
Bioinformatics
,
Cell division
2020
Mutations in the CDC14A (Cell Division-Cycle 14A) gene, which encodes a conserved dual-specificity protein tyrosine phosphatase, have been identified as a cause of autosomal recessive non-syndromic hearing loss (DFNB32) and hearing impairment infertility male syndrome (HIIMS). We used next-generation sequencing to screen six deaf probands from six families segregating sensorineural moderate-to-profound hearing loss. Data analysis and variant prioritization were completed using a custom bioinformatics pipeline. We identified three homozygous loss of function variants (p.Arg345Ter, p.Arg376Ter, and p.Ala451Thrfs*43) in the CDC14A gene, segregating with deafness in each family. Of the six families, four segregated the p.Arg376Ter mutation, one family segregated the p.Arg345Ter mutation and one family segregated a novel frameshift (p.Ala451Thrfs*43) mutation. In-depth phenotyping of affected individuals ruled out secondary syndromic findings. This study implicates the p.Arg376Ter mutation might be as a founder mutation in the Iranian population. It also provides the first semen analysis for deaf males carrying mutations in exon 11 of CDC14A and reveals a genotype–phenotype correlation that delineates between DFNB32 and HIIMS. The clinical results from affected males suggest the NM_033313.2 transcript alone is sufficient for proper male fertility, but not for proper auditory function. We conclude that DFNB32 is a distinct phenotypic entity in males.
Journal Article
Social Engagement, Cognition, Depression, and Comorbidity in Nursing Home Residents With Sensory Impairment
2019
Sensory impairment, explicitly vision and hearing impairment, among nursing home (NH) residents decreases their ability to socially engage. However, it is not known to what extent visual, hearing, or dual impairment is associated with social engagement. The aims of the current retrospective, cross-sectional descriptive study were to determine the relationship between social engagement and (a) levels of sensory impairment (vision, hearing, and dual); (b) depression; and (c) cognition. The authors analyzed baseline data from 213 NH residents with sensory impairment from the I-SEE study. Multivariable model results demonstrated that sensory impairment was not associated with social engagement when adjusting for all covariates. Greater social engagement was associated with less depression, better cognition, and greater comorbidity. Clinicians should be aware of these risks to social engagement in NH residents with sensory impairment and monitor for decreased social engagement and isolation in residents with less comorbidities, higher depression levels, and poorer cognition. [Res Gerontol Nurs. 2019; 12(5):217–226.]
Journal Article
Increased risk of sudden sensorineural hearing loss in patients with cervical spondylosis
2024
Whether cervical spondylosis (CS) is a risk factor for sudden sensorineural hearing loss (SSNHL) remains unclear. This study used national population-based data to investigate the risk of SSNHL in patients with CS in Taiwan of different ages and sexes. This study used data covering 2 million people in Taiwan, which were obtained from the National Health Insurance Research Database. The data that support the findings of this study are available from National Health Insurance Research Database but restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. Data are however available from the corresponding authors upon reasonable request and with permission of National Health Insurance Research Database. This retrospective cohort study enrolled 91,587 patients with a newly diagnosed CS between January 2000 and December 2018. Case and control cohorts were matched 1:1 according to age, sex, and comorbidities. SSNHL incidence rate and risk were compared between the groups. Cox regression was used to estimate hazard ratios (HRs) and 95% confidence intervals (CIs). The mean follow-up period was 8.80 (SD = 4.12) and 8.24 (SD = 4.09) years in the CS and control cohorts, respectively. The incidence rate of SSNHL in the CS cohort (85.28 per 100 000 person-years) was 1.49-fold significantly higher than that in the non-CS cohort (57.13 per 100,000 person-years) (95% CI 1.32–1.68,
P
< .001). After age, sex, and selected comorbidities were adjusted for, CS exhibited an independent risk factor for SSNHL (adjusted HR = 1.52; 95% CI 1.34–1.71,
P
< .001). An age-stratified analysis in this study demonstrated a strong and highly significant association between CS and SSNHL in patients aged < 35 years (IRR = 2.28, 95% CI 1.18–4.39,
P
= .013). This large-scale Taiwanese-population-based retrospective study found that CS was associated with an increased risk of SSNHL. Acute hearing loss in patients with CS, particularly at a young age, should be carefully evaluated, and prompt treatment for SSNHL should be initiated.
Journal Article