Hearing Loss/Impairment

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Hearing Loss/Impairment and Deafness

General Purpose:

Permanent hearing loss results when the inner ear or the auditory nerve becomes damaged. Temporary hearing loss can occur when sound waves are prevented from reaching the inner ear by a buildup of earwax, excess fluid, or a punctured eardrum. If left untreated, hearing problems can become worse over time. They can also lead to depression and anxiety.

Hearing loss and deafness can be caused by any number of factors, including genetics, ear infections, meningitis (inflammation of the lining that surrounds the brain and spinal cord), trauma, medications, prolonged exposure to loud noises, and aging. Deafness can also be present at birth.

Each year, approximately 3 out of every 1,000 children born in the United States are born deaf or hearing-impaired, and even more lose their hearing during childhood. Children who are born deaf often have a genetic abnormality that causes their deafness, while others may lose their hearing as a result of a pregnancy complication.

Rubella, cytomegalovirus, toxoplasmosis, and herpes can all cause a child to be born deaf. Certain medications, when consumed by the mother during pregnancy, can also lead to deafness in the baby.

Following birth, prematurity, infections, extreme jaundice, and oxygen deprivation can also lead to deafness in infants. During childhood, infection with measles, mumps, or meningitis can cause children to permanently lose their hearing.

The signs and symptoms of hearing loss can vary and may include any of the following: muffling of speech and other sounds; difficulty understanding words (especially when in a crowd in the presence of background noise); the constant need to ask individuals to speak louder, slower, or more clearly; the need to increase the volume of the television or radio; hesitance to engage in conversation; and avoidance of certain social scenarios.

Hearing loss and deafness can be a considerable source of frustration for those who suffer from these conditions. Fortunately, effective treatments are available that can improve the hearing of individuals with hearing disorders, and new devices and therapies are constantly being researched and tested.

Furthermore, scientists have recently identified genes that are associated with hearing loss, and are working hard to use this information to develop better methods of prevention and treatment.

What Will Hearing Loss and Deafness Clinical Trials Be like?

When participating in a clinical trial designed to investigate some aspect related to hearing loss or deafness, there are a few basic tests and procedures you may receive; however, the ultimate design of the particular study will determine which specific procedures you will undergo. The following is a list of some tests and procedures that may be used in clinical trials for hearing loss or deafness:

  • Detailed physical examination and medical history
  • Basic hearing screening tests
  • Tuning fork tests: these two-pronged metal instruments produce sounds when struck, and may help doctors detect hearing loss and identify what is causing the hearing impairment.
  • Audiometer tests: a test in which the individual wears earphones and hears sounds directed into one ear at a time. A range of sounds and tones are presented and individuals are asked to indicate each time that they are able to hear one. Words are also used in this test.
  • You may be asked to wear a hearing aid (a small device that attaches to the ear and makes sounds stronger and easier to hear) or a cochlear implant (a tiny implantable device that replaces the damaged portions of the inner ear and can improve hearing).
  • Imaging procedures such as computed tomography (CT scan, or “CAT scan”) or magnetic resonance imaging (MRI) scans. These imaging procedures are non-invasive, similar to x-rays, and provide detailed pictures of areas inside your body.

Typical Hearing Loss and Deafness Clinical Trial Protocol:

Specific examples of clinical trials for hearing loss and deafness might include the following:

  • An experimental study to determine if a newly developed steroid medication (not yet approved for treatment of sudden hearing loss) can be used to treat sudden hearing loss.
  • A randomized clinical trial to determine if use of the drug dexamethasone is effective at preventing chemotherapy-induced hearing loss among cancer patients. In this study, half of the patients would receive the drug and half would receive a placebo.
  • An observational study of individuals between the ages of two and 30 who were born with hypothyroidism (also called congenital hypothyroidism, a condition characterized by a low-functioning thyroid gland). This study would aim to determine the prevalence of hearing loss among children with congenital hypothyroidism and compare their clinical, biological, and genetic characteristics to individuals with and without hearing loss (but who do not have congenital hypothyroidism).
  • A clinical trial to measure the effects of a hearing aid on the functioning, disability, and overall quality of life of adults with hearing loss.

A brief word about randomized trials and placebos:

Many clinical trials involve the comparison of an investigational treatment to a “standard” treatment. Some studies determine which therapy a patient receives through a process known as randomization, in which patients are randomly assigned to receive either the investigational treatment or the standard treatment.

On occasion, a trial will investigate the use of a standard treatment plus a new drug compared to standard treatment plus a placebo. Placebos are inactive or “sham” treatments that are identical in appearance to the active treatment but have no therapeutic value.

Placebos are necessary to help determine if adverse effects that occur during the clinical trial are the result of the investigational treatment or due to some other factor. They also allow researchers to measure the effects of the active treatment and observe what would have happened without it.

In rare instances where no standard therapy exists, or when a new drug is being evaluated for the first time, the investigational treatment might be compared to a placebo alone (such as in the second example provided above). In these types of trials, those patients who are randomized to the placebo group do not receive an active treatment.

It is important to know that placebo-only trials are only conducted when scientifically necessary and when patients have been adequately informed that they may end up receiving the placebo rather than the active treatment.

It is very important to note, however, that no one should ever participate in such a placebo trial when there is a widely available and highly effective standard treatment already in existence for their particular disease or condition.

Trial Eligibility and Medical Information Needed:

The type of clinical trial you may be eligible for often depends on many factors. Therefore, it is important to know many details pertaining to your specific diagnosis when searching for clinical trials. Examples of the details you may want to have on hand include:

  • The cause of your hearing impairment (if known)
  • Family history of hearing impairment
  • A list of your current medications (including prescription, non-prescription, vitamins, and dietary supplements)
  • A list of your previous treatments for hearing impairment (including hearing aids, cochlear implants, surgery)

Suggested Search Terms:

“congenital deafness,” “sudden deafness,” “deafness genetics,” “deafness children,” “deafness pediatrics,” “deafness infection,” “sudden hearing loss,” “hearing loss children,” “hearing loss pediatric,” “hearing loss medication,” “hearing loss side effect,” “hearing loss treatment,” “hearing loss prevention,” “hearing loss surgery,” and “hearing loss age.”

Current Search Term:

“Hearing Loss/Impairment”

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Treating Hearing Loss to Improve Mood and Cognition in Older Adults


Conditions:   Hearing Loss;   Depression
Interventions:   Device: Audio B-R 90 hearing aid device;   Drug: Duloxetine
Sponsor:   New York State Psychiatric Institute
Recruiting


Risk Factors for Hearing Loss as a Result of Exposure to Noise During Military Training in the IDF


Condition:   Hearing Loss, Noise-Induced
Intervention:   Other: Guidance on auditory protection
Sponsor:   Medical Corps, Israel Defense Force
Recruiting


Reducing Childhood Hearing Loss in an Alaska Native Population Through a New School Screening and Referral Process That Utilizes Mobile Health and Telemedicine


Condition:   Hearing Loss
Interventions:   Other: Current Primary Care Referral Process;   Other: Telemedicine Referral Process
Sponsors:   Norton Sound Health Corporation;   Duke University;   Johns Hopkins University;   Patient-Centered Outcomes Research Institute
Recruiting


High Dose Oral Steroids in Sudden Sensorineural Hearing Loss


Condition:   Sudden Sensorineural Hearing Loss (SSNHL)
Interventions:   Drug: Dexamethasone;   Drug: Prednisone
Sponsor:   University of Colorado, Denver
Recruiting


Cochlear Implantation in Adults With Asymmetric Hearing Loss Clinical Trial


Condition:   Hearing Loss
Intervention:   Device: Cochlear implant
Sponsors:   Washington University School of Medicine;   Midwest Ear Institute;   House Clinic, Inc.;   New York University School of Medicine
Recruiting


Cochlear Implantation in Pediatric Cases of Unilateral Hearing Loss


Condition:   Hearing Loss, Unilateral
Intervention:   Device: Cochlear implant
Sponsors:   University of North Carolina, Chapel Hill;   Med-El Corporation
Recruiting


Phase 3 Clinical Trial: D-methionine to Reduce Noise-Induced Hearing Loss (NIHL)


Condition:   Noise-induced Hearing Loss
Interventions:   Drug: D-methionine;   Drug: Placebo
Sponsor:   Southern Illinois University
Terminated


Rilonacept for Treatment of Autoimmune Neurosensory Hearing Loss


Condition:   Autoimmune Neurosensory Hearing Loss (ANSHL)
Intervention:   Drug: Rilonacept
Sponsors:   Stanley Cohen;   Regeneron Pharmaceuticals
Recruiting


Efficacy and Safety of AM-111 as Acute Sudden Sensorineural Hearing Loss Treatment


Condition:   Hearing Loss, Idiopathic Sudden Sensorineural
Interventions:   Drug: AM-111 0.4 mg/ml;   Drug: AM-111 0.8 mg/ml;   Other: Placebo
Sponsor:   Auris Medical, Inc.
Recruiting


A Phase 2b Study of SPI-1005 to Reduce the Incidence, Severity, and Duration of Acute Noise Induced Hearing Loss


Condition:   Noise Induced Hearing Loss
Interventions:   Drug: SPI-1005 200mg;   Drug: SPI-1005 400mg;   Drug: Placebo
Sponsor:   Sound Pharmaceuticals, Incorporated
Not yet recruiting


AM-111 in the Treatment of Acute Inner Ear Hearing Loss


Condition:   Hearing Loss
Interventions:   Other: Placebo;   Drug: AM-111 0.4 mg/ml;   Drug: AM-111 0.8 mg/ml
Sponsor:   Auris Medical AG
Completed


Hearing Handicap in Patients With Single Sided Deafness


Condition:   Hearing Loss
Intervention:   Device: Hearing Aid
Sponsor:   Cambridge University Hospitals NHS Foundation Trust
Withdrawn


Efficacy and Safety of AUT00063 Versus Placebo in Age-Related Hearing Loss


Condition:   Age-Related Hearing Loss
Interventions:   Drug: AUT00063;   Drug: Placebo
Sponsor:   Autifony Therapeutics Limited
Completed


Use of Amplification in Children With Unilateral Hearing Loss


Condition:   Unilateral Hearing Loss
Intervention:   Device: Hearing aid
Sponsor:   Massachusetts Eye and Ear Infirmary
Recruiting


Tele-educative Program to Improve Adherence to the Use of Hearing Aids in Patients With Hearing Loss


Condition:   Hearing Loss
Interventions:   Behavioral: Active Communication Education Program;   Other: Control
Sponsors:   University of Chile;   Comisión Nacional de Investigación Científica y Tecnológica
Completed


Cochlear Implantation in Cases of Single-Sided Deafness


Conditions:   Unilateral Moderate to Profound Hearing Loss, Single-Sided Deafness (SSD);   Asymmetric Hearing Loss
Interventions:   Device: Cochlear Implant;   Other: Control Group
Sponsors:   University of North Carolina, Chapel Hill;   Med-El Corporation
Active, not recruiting


Safety, Tolerability and Efficacy for CGF166 in Patients With Bilateral Severe-to-profound Hearing Loss


Condition:   Bilateral Severe to Profound Hearing Loss
Intervention:   Drug: CGF166
Sponsor:   Novartis Pharmaceuticals
Recruiting


Cochlear Implantation Among Adults and Older Children With Unilateral or Asymmetric Hearing Loss


Condition:   Severe Unilateral Sensorineural Hearing Loss
Intervention:   Device: Cochlear implant
Sponsor:   Mayo Clinic
Recruiting


Long QT and Hearing Loss Registry


Conditions:   Sensorineural Hearing Loss;   Long QT Syndrome
Intervention:  
Sponsor:   Mednax Center for Research, Education and Quality
Recruiting


Prevention of Noise-induced Hearing Loss


Condition:   Noise-induced Hearing Loss
Interventions:   Drug: Zonisamide;   Drug: Methylprednisolone
Sponsor:   Washington University School of Medicine
Withdrawn


Clinical Study of Cochlear Implants in Adults With Asymmetrical Hearing Loss


Condition:   Hearing Loss
Intervention:   Procedure: Cochlear Implantation
Sponsors:   Washington University School of Medicine;   National Institute on Deafness and Other Communication Disorders (NIDCD)
Active, not recruiting


Assessment of the ACE Program for Rehabilitation in Hearing Loss


Condition:   Hearing Loss
Interventions:   Behavioral: Active Communication Education Program;   Other: Control
Sponsor:   University of Chile
Completed


Phase 3 Clinical Trial: D-methionine to Reduce Noise-Induced Hearing Loss (NIHL)


Condition:   Noise-Induced Hearing Loss
Interventions:   Drug: D-methionine, oral liquid suspension;   Other: Placebo Comparator
Sponsors:   MetArmor;   United States Department of Defense
Terminated


Micronutrients to Prevent Noise-induced Hearing Loss


Condition:   Noise-Induced Hearing Loss
Interventions:   Drug: beta-carotene, vitamins C and E, magnesium;   Other: Placebo
Sponsors:   University of Michigan;   National Institute on Deafness and Other Communication Disorders (NIDCD);   University of Florida;   Southern Illinois University;   Hearing Health Science, Inc.
Completed


Genetic Analysis of Human Hereditary Hearing Impairment


Condition:   Partial Hearing Loss
Intervention:  
Sponsor:   National Institute on Deafness and Other Communication Disorders (NIDCD)
Terminated

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