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Purpose Specific classes of antibiotics, such as aminoglycosides, have well-established adverse events producing permanent hearing loss, tinnitus, and balance and/or vestibular problems (i.e., ototoxicity). Although these antibiotics are frequently used to treat pseudomonas and other bacterial infections in patients with cystic fibrosis (CF), there are no formalized recommendations describing approaches to implementation of guideline adherent ototoxicity monitoring as part of CF clinical care. Method This consensus statement was developed by the International Ototoxicity Management Working Group (IOMG) Ad Hoc Committee on Aminoglycoside Antibiotics to address the clinical need for ototoxicity management in CF patients treated with known ototoxic medications. These clinical protocol considerations were created using consensus opinion from a community of international experts and available evidence specific to patients with CF, as well as published national and international guidelines on ototoxicity monitoring. Results The IOMG advocates four clinical recommendations for implementing routine and guideline adherent ototoxicity management in patients with CF. These are (a) including questions about hearing, tinnitus, and balance/vestibular problems as part of the routine CF case history for all patients; (b) utilizing timely point-of-care measures; (c) establishing a baseline and conducting posttreatment evaluations for each course of intravenous ototoxic drug treatment; and (d) repeating annual hearing and vestibular evaluations for all patients with a history of ototoxic antibiotic exposure. Conclusion Increased efforts for implementation of an ototoxicity management program in the CF care team model will improve identification of ototoxicity signs and symptoms, allow for timely therapeutic follow-up, and provide the clinician and patient an opportunity to make an informed decision about potential treatment modifications to minimize adverse events. Supplemental Material https://doi.org/10.23641/asha.16624366

BACKGROUND: Cisplatin is widely used to treat adult and pediatric cancers. It is the most ototoxic drug in clinical use, resulting in permanent hearing loss in approximately 50% of treated patients. There is a major need for therapies that prevent cisplatin-induced hearing loss. Studies in mice suggest that concurrent use of statins reduces cisplatin-induced hearing loss. METHODS: We examined hearing thresholds from 277 adults treated with cisplatin for head and neck cancer. Pretreatment and posttreatment audiograms were collected within 90 days of initiation and completion of cisplatin therapy. The primary outcome measure was a change in hearing as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE). RESULTS: Among patients on concurrent atorvastatin, 9.7% experienced a CTCAE grade 2 or higher cisplatin-induced hearing loss compared with 29.4% in nonstatin users (P < 0.0001). A mixed-effect model analysis showed that atorvastatin use was significantly associated with reduced cisplatin-induced hearing loss (P ≤ 0.01). An adjusted odds ratio (OR) analysis indicated that an atorvastatin user is 53% less likely to acquire a cisplatin-induced hearing loss than a nonstatin user (OR = 0.47; 95% CI, 0.30–0.78). Three-year survival rates were not different between atorvastatin users and nonstatin users (P > 0.05). CONCLUSIONS: Our data indicate that atorvastatin use is associated with reduced incidence and severity of cisplatin-induced hearing loss in adults being treated for head and neck cancer. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT03225157. FUNDING: Funding was provided by the Division of Intramural Research at the National Institute on Deafness and Other Communication Disorders (1 ZIA DC000079, ZIA DC000090).

Introduction The number-one service-connected disability is tinnitus. Tinnitus currently has no cure, but the functional impact of tinnitus has been shown to be mitigated by Progressive Tinnitus Management (PTM), a multi-level management approach. The duration of PTM Level 3 skills education (PTM-SE) and the inclusion of mental health providers have been identified as barriers to implementation of PTM-SE in Department of Defense (DOD) medical treatment facilities. The goal of this study was to determine if a version of PTM-SE modified for use in DOD medical treatment facilities resulted in positive changes in tinnitus-related outcomes. Materials and Methods A retrospective study was conducted by examining the medical records of patients who attended modified PTM-SE appointments. The study was approved by the Walter Reed National Military Medical Center Institutional Review Board. The study sample included 130 patients who completed modified PTM-SE between January 2015 and June 2016. Primary outcome measures were tinnitus awareness and tinnitus annoyance; secondary outcome measures were effect on life and self-perceived coping ability. Outcome measures were analyzed with nonparametric statistics and logistic regression. Results Modified PTM-SE resulted in clinically significant improvements in the primary outcome measures (awareness, p < 0.0001; annoyance, p < 0.0001). The proportion of patients who indicated an improvement in coping with tinnitus was similar to other published data with similar modifications to PTM-SE. Conclusions The evidence supports the assumption that PTM is a flexible program of tinnitus management that even when modified to be suitable for use in a DOD medical treatment facility provides meaningful reductions in tinnitus awareness and annoyance and improves tinnitus coping ability among military beneficiaries. These findings should encourage audiologists to modify PTM to work within their military medical treatment facility.

OBJECTIVES: To promote establishment of more uniformly effective ototoxicity monitoring programs (OMPs), this report reviews the U.S. national audiology guidelines in relation to “real world” OMP application. A secondary aim is to review the mechanisms, risk and clinical presentation of hearing loss associated with major classes of ototoxic medications. DESIGN: This is a non-systematic review using PubMed, national and international agency websites, personal communications between ototoxicity experts, and results of unpublished research. Examples are provided of OMPs in various healthcare settings within the U.S. civilian sector, Department of Defense (DoD), and Department of Veterans Affairs (VA). STUDY SAMPLE: The five OMPs compared in this report represent a convenience sample of the programs with which the authors are affiliated. Their opinions were elicited via two semi-structured teleconferences on barriers and facilitators of OMP, followed by a self-administered questionnaire on OMP characteristics and practices, with responses synthesized and tabulated herein. Preliminary results are provided from an ongoing VA clinical trial at one of these OMP sites. Participants were 40 VA patients who received cisplatin chemotherapy in 2014-2017. The study arms contrast access to care for OMP delivered on the treatment unit versus usual care as provided in the audiology clinic. RESULTS: Protocols of the OMPs examined vary, reflecting the diverse settings in which they exist. Service delivery concerns included baseline tests missed or completed after the initial treatment, and monitoring tests done infrequently or only after cessation of treatment. Perceived barriers involved logistics related to accessing and testing patients, such as a lack of processes to help patients enter programs, patients’ time and scheduling constraints, and inconvenient audiology clinic locations. Most sites routinely used abbreviated or screening methods to facilitate monitoring. CONCLUSIONS: The most effective OMPs integrated audiological management into the care pathways of the clinical specialties that prescribe ototoxic medications. More OMP guidance is needed to inform evaluation schedules, outcome reporting, and determination of an actionable ototoxic change. Guidance is also lacking on the potential use of hearing conservation approaches suitable for the mass testing needed to support large-scale OMP efforts. Guideline adherence might improve with formal endorsement from the organizations governing medical specialty stakeholders in OMP such as medical oncologists, pulmonologists, infectious disease specialists, and ototolaryngologists.