单侧助听器使用者中基于真耳测量的验配结局：对侧听力的影响

文献信息

中文摘要

目的： 真耳测量（REM）常用于验证助听器验配；然而，其在单侧使用者中相对于非REM验配的附加获益以及对侧耳听力的影响仍不明确。在这项回顾性研究中，我们比较了单侧助听器使用者中基于REM的验配路径与制造商首次验配后常规临床微调路径之间的短期听力学和患者报告结局，并检查了与对侧耳听力的关联。
方法： 我们回顾性分析了105名单侧助听器使用者的数据，随访3个月（REM：n=60；非REM：n=45）。基线测量包括助听耳（即佩戴助听器的耳）和对侧耳（即对侧耳）的纯音平均值（PTA4），以及老年听力障碍量表（HHIE）。结局包括声场功能增益（ΔPTA4）、达到≥10 dB增益、HHIE变化（ΔHHIE；应答者定义为降低≥18分）以及3个月时助听器国际结局量表（IOI-HA）评分。组间比较采用非参数检验，并使用多变量线性和逻辑回归模型调整人口学和听力学协变量。对侧耳听力与结局之间的关联采用相关性和亚组分析进行检查。
结果： 两组基线特征总体可比，尽管验配侧存在差异。3个月时，REM组平均功能增益为11.0±10.6 dB HL，非REM组为9.1±10.1 dB HL（p=0.2145）。平均ΔHHIE分别为25.7±30.3分和32.9±28.6分（p=0.1680），平均IOI-HA评分分别为24.4±6.7和23.9±5.9（p=0.9492）。在调整分析中，基于REM的验配路径与ΔHHIE（β=1.97；95% CI，-3.12至7.06）或3个月IOI-HA评分（β=0.32；95% CI，-2.23至2.86）无关。较差的对侧耳PTA4与更大的HHIE改善相关（r=0.389，p<0.001）。
结论： 在这项单侧助听器使用者的回顾性队列中，与制造商首次验配后常规微调相比，基于REM的验配路径与3个月听力学或患者报告结局的统计学显著差异无关；这并未确立等效性或分离REM的效果。对侧耳听力与感知障碍改善相关，可能与结局解读和咨询有关。

英文摘要

OBJECTIVES: Real-ear measurement (REM) is commonly used to verify hearing aid fittings; however, its added benefit over non-REM fitting in unilateral users and the influence of contralateral ear hearing remain unclear. In this retrospective study, we compared short-term audiometric and patient-reported outcomes between an REM-based fitting pathway and a manufacturer-first-fit pathway followed by routine clinical fine-tuning in unilateral hearing-aid users, and examined associations with contralateral-ear hearing.
METHODS: We retrospectively analyzed data from 105 unilateral hearing aid users with 3 months of follow-up (REM: n = 60; non-REM: n = 45). Baseline measures included pure-tone averages (PTA4) of the aided ear (i.e., the ear fitted with the hearing aid) and contralateral ear (i.e., the opposite ear), as well as the Hearing Handicap Inventory for the Elderly (HHIE). Outcomes included sound-field functional gain (ΔPTA4), achievement of ≥10 dB gain, change in HHIE (ΔHHIE; responder ≥18-point reduction), and the International Outcome Inventory for Hearing Aids (IOI-HA) scores at 3 months. Group comparisons were performed using non-parametric tests, and multivariable linear and logistic regression models were used to adjust for demographic and audiometric covariates. Associations between contralateral ear hearing and outcomes were examined using correlation and subgroup analyses.
RESULTS: Baseline characteristics were generally comparable between groups, although fitted side differed. At 3 months, mean functional gain was 11.0 ± 10.6 dB HL in the REM group and 9.1 ± 10.1 dB HL in the non-REM group (p = 0.2145). Mean ΔHHIE was 25.7 ± 30.3 and 32.9 ± 28.6 points (p = 0.1680), and mean IOI-HA scores were 24.4 ± 6.7 and 23.9 ± 5.9, respectively (p = 0.9492). In adjusted analyses, the REM-based fitting pathway was not associated with ΔHHIE (β = 1.97; 95% CI, -3.12 to 7.06) or 3-month IOI-HA score (β = 0.32; 95% CI, -2.23 to 2.86). Worse contralateral-ear PTA4 was associated with greater HHIE improvement (r = 0.389, p < 0.001).
CONCLUSION: In this retrospective cohort of unilateral hearing-aid users, an REM-based fitting pathway was not associated with statistically significant 3-month audiometric or patient-reported outcome differences compared with manufacturer first-fit followed by routine fine-tuning; this does not establish equivalence or isolate the effect of REM. Contralateral-ear hearing was associated with perceived handicap improvement and may be relevant to outcome interpretation and counseling.