In a prespecified secondary analysis of the Aspirin in Reducing Events in the Elderly (ASPREE) randomized clinical trial, low-dose aspirin was not found to affect the progression of age-related hearing loss over 3 years in healthy older adults, according to a study.

In the double-blind, placebo-controlled study, published in JAMA Network Open, researchers recruited 279 Australian adults aged 70 years or older who did not have cardiovascular disease, dementia, and life-limiting conditions at baseline. The participants were recruited between January 1, 2010, and December 31, 2014, and followed-up over 3 years, with statistical analysis completed from June to December 2023. They were randomized 1:1 to receive either 100 mg of daily enteric-coated aspirin or matching placebo.

Air conduction audiometry and speech perception in noise were assessed at baseline, 18 months, and 3 years. The primary outcome of the study was the change in mean sound detection thresholds from baseline to 3 years. Analysis was based on intention to treat, using mixed linear regression models.

At baseline, the median age of the participants was 73.1 years and 55% of them were male. Approximately 70% of the participants in both groups had some hearing loss. In the aspirin group, 17% reported using hearing aids and 17% reported a history of loud noise exposure in the previous 5 years compared with 19% and 8% in the placebo group, respectively. The proportions of never-smokers (56% vs 57%) and those who never consumed alcohol (15% vs 13%) were similar between the participants who received aspirin and those who received placebo, respectively.

Most participants were nonfrail (aspirin = 71% vs placebo = 68%) and free from diabetes (89% vs 86%) at baseline. Hypertension was reported in 70% of the participants in the aspirin group and 72% of those in the placebo group. Study medication adherence, measured by pill count during the 6-month follow-up telephone call, was approximately 70% for both groups.

Over the 3-year follow-up, hearing thresholds increased by about 3 dB in both groups, with no significant difference between aspirin and placebo (P = .55). Specifically, the 4-frequency average (4FA) hearing threshold changes were:

• Aspirin: baseline 27.8 dB, year 3 30.7 dB (difference = 3.3 dB) 
• Placebo: baseline 27.5 dB, year 3 30.9 dB (difference = 3.0 dB).

The findings were consistent across all tested frequencies (0.25, 0.5, 1, 2, 4, and 8 kHz). Similarly, speech reception thresholds worsened by 0.9 dB in both groups (P = .86). The results remained unchanged after adjustment for age, sex, diabetes, and smoking and in subgroup analyses stratified by age, sex, diabetes, and smoking status.

Self-reported hearing handicap using the Hearing Handicap Inventory for the Elderly Screening Version (HHIE-S) was 31% among those in the placebo group and 34% among the participants in the aspirin group at baseline. By year 3, the prevalence increased modestly but remained similar between groups (39% for placebo vs 37% for aspirin).

Sensitivity analyses including participants who completed their year 3 hearing assessment within 3 months (n = 544) or 6 months (n = 904) after trial closure were consistent with the primary results, showing no differences between the aspirin and placebo groups.

The study was limited by its small sample size and modest duration of follow-up. Additionally, the study relied on pure-tone audiometry, which requires volitional responses to auditory stimuli. The researchers noted that more investigation is warranted on whether a longer follow-up or use of a more powerful anti-inflammatory agent might prove beneficial.

The authors reported no conflicts of interest.