Natural History of Untreated Idiopathic Sudden Sensorineural Hearing Loss.
Yu-Lan Mary YingChristopher C TsengJennifer ShinSteven RauchPublished in: The Laryngoscope (2024)
The observed natural history of ISSNHL suggests that patients can regain some hearing without active treatment. In the absence of future studies collecting prospective natural history data from untreated or placebo-treated ISSNHL patients, the data presented here provide the best available historical control data for reconsideration of results in past ISSNHL studies, as well as a roadmap for design and interpretation of future ISSNHL treatment clinical trials. Furthermore, knowing there is a statistically significant mean hearing gain of 24.0 dB HL in the untreated/placebo group provides an ethical basis for future placebo study of ISSNHL. The current status on ISSNHL management calls for a multi-institutional, randomized, double-blind placebo-controlled trial with validated outcome measures to provide science-based treatment guidance. Laryngoscope, 134:S1-S15, 2024.
Keyphrases
- double blind
- current status
- placebo controlled
- clinical trial
- phase iii
- newly diagnosed
- end stage renal disease
- ejection fraction
- electronic health record
- prognostic factors
- study protocol
- big data
- public health
- phase ii
- machine learning
- combination therapy
- patient reported
- randomized controlled trial
- case control
- smoking cessation
- gastric bypass