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3 Study Matches
Evaluation of Revised Indicatons (ERID) for Cochlear Implant Candidacy for the Adult CMS Population
Purpose: The purpose of this study is 1) to evaluate the safety and efficacy of currently available multichannel cochlear implant systems for newly implanted adults with an indication based on open-set sentence recognition that expand criteria currently used by Center for Medicare & Medicaid Services (CMS), and 2) to assess the correlation between measures of speech recognition in candidates for cochlear implants and their utility in predicting audiologic and quality of life outcomes after implantation. Participants: Adults (â‰¥ 65 years of age) and CMS-eligible as a primary source of medical insurance coverage. Procedures (methods): Evaluate objective and subjective outcomes of cochlear implantation in a patient population that does not meet current CMS candidacy criteria.
65 Years and over
• Sixty-five years of age or older at the time of the study and CMS-eligible as primary source of medical insurance coverage.
• Bilateral moderate to profound hearing loss in the low frequencies (up to 1000 Hz) and profound sensorineural hearing loss in the high frequencies (3000 Hz and above).
• Preoperative aided sentence score in quiet greater than or equal to 40% correct but less than or equal to 60% correct in the best aided condition on recorded AzBio sentences.
• English spoken as the primary language.
• Congenital hearing loss (for the purpose of this study, onset pror to 2 years-of-age).
• Preoperative aided sentence score less than 40% or greater than 60% correct in the best aided condition on AzBio sentences in quiet
• Ossification, absence of cochlear development or any other cochlear anomaly that might prevent complete insertion of the electrode array.
• Hearing loss of neural or central origin (e.g., deafness due to lesions on the acoustic nerve or central auditory pathway).
• Active middle-ear infection.
• The audiologist and/or surgeon will review the study protocol with the patient prior to having him/her sign the consent form. If the patient indicates he/she is unwilling or unable to comply with all investigational requirements, he/she will not be enrolled in the study.
• Using best clinical judgment based on professional interaction with the patient and his/her family, the managing audiologist and surgeon will determine if there are any disabling cognitive limitations that would prevent the patient from providing reliable data for this study.
Device: Cochlear implant
Bilateral Sensorineural Hearing Loss
Cochlear Implant, Post-lingual onset hearing loss, Profound hearing loss, Low Frequency hearing loss, Profound sensorineural hearing loss, High frequency hearing loss, CMS-eligible patients
SPI-1005 for the Treatment of Patients With Meniere's Disease
18 Years to 75 Years old
• Adult male and female patients, 18-75 years of age at the time of enrollment.
• Diagnosis of probable or definitive Meniere's disease by AAOHNS 1995 criteria.
• Two of three active symptoms including vertigo or disequilibrium, fluctuating hearing loss, or tinnitus within the 3 months prior to study enrollment.
• Hearing loss of ≥ 30 dBHL at either 250, 500 or 1000 Hz.
• Voluntary consent to participate in the study.
• Male subjects that are willing to use condoms throughout the study period and 90-days following study completion even if not fertile.
• Females of childbearing potential should either be sexually inactive (abstinent) for 14 days prior to screening and throughout the study or be using one of the following acceptable birth control methods:
• IUD in place for at least 3 months prior to study; or
• Barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening through study completion; or
• Stable hormonal contraceptive for at least 3 months prior to study and through study completion; or
• Surgical sterilization (vasectomy) of partner at least 6 months prior to study enrollment.
• Females of non-childbearing potential should be surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study enrollment, hysterectomy, or bilateral oophorectomy at least 2 months prior to study) or be at least 1 year since last menses.
• Current use of or within 60 days prior to study IV ototoxic medications such as chemotherapy including cisplatin, carboplatinum, or oxaliplatin; aminoglycoside antibiotics including gentamicin, amikacin, tobramycin, kanamycin, or streptomycin; or loop diuretics including furosemide.
• History of otosclerosis or vestibular schwannoma.
• History of significant middle ear or inner ear surgery.
• Current conductive hearing loss, otitis media, or mixed hearing loss.
• Significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, or psychiatric disease.
• Current use or within 30 days prior to study enrollment systemic steroids or drugs known to be strong inhibitors or inducers of cytochrome P450 enzymes.
• Hypersensitivity or idiosyncratic reaction to compounds related to ebselen or selenium.
• Female patients who are pregnant or breastfeeding.
• Participation in another interventional drug or device study within 30 days prior to study consent.
Drug: 200mg SPI-1005 BID, Drug: 400mg SPI-1005 BID, Other: Placebo
Meniere's disease, Hearing Loss, Vertigo, Tinnitus, Ebselen, Pharmacokinetics, Safety, Efficacy, Speech
SPI-1005 for Prevention and Treatment of Aminoglycoside Induced Ototoxicity
18 Years and over
Phase 1/Phase 2
• Cystic fibrosis patients about to receive IV tobramycin for acute pulmonary exacerbation.
• Voluntarily consent to participate in the study.
• Females of childbearing potential should be using and committed to continue using one of the following acceptable birth control methods:
• Sexual abstinence (inactivity) for 14 days prior to screening through study completion; or IUD in place for at least 3 months prior to study through study completion; or Barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening through study completion; or Stable hormonal contraceptive for at least 3 months prior to study through study completion.
• Ability to perform all behavioral tests as indicated.
• Current use or within 60 days prior to study enrollment the following IV ototoxic medications: aminoglycoside antibiotics (gentamicin, tobramycin, amikacin, streptomycin); platinum-containing chemotherapies (cisplatin, carboplatin, oxaliplatin); or loop diuretic (furosemide).
• History of idiopathic sensorineural hearing loss, otosclerosis, or vestibular schwannoma.
• History of middle ear or inner ear surgery.
• Current conductive hearing loss or middle ear effusion.
• Significant cardiovascular, hepatic, renal, hematologic, endocrine, immunologic, or psychiatric disease.
• History of hypersensitivity or idiosyncratic reaction to compounds related to ebselen.
• Participation in another investigational drug or device study within 30 days prior to study enrollment.
• Female patients who are pregnant or breastfeeding.
Drug: Placebo, Drug: SPI-1005 Ebselen 200mg Capsule x1, Drug: SPI-1005 Ebselen 200mg Capsule x2, Drug: SPI-1005 Ebselen 200mg Capsule x3