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临床试验/RBR-6fntmd
RBR-6fntmd进行中(未招募)未知

Assessment of the potential of hearing improvement by performing a double-blind, randomized, cross-over study in the state of São Paulo. Consumer satisfaction with sound amplification in everyday life with a new high-performance hearing aid - WHO Inc. compared to advanced digital hearing aids available on the market

niversidade de São Paulo0 个研究点开始时间: 2019年4月30日最近更新:
适应症

试验速览

阶段
未知
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Intervention

入排标准

年龄范围
21Y 至 75Y(—)

入选标准

  • Sensorineural hearing loss with tonal thresholds of 25-85 dB NA per octave frequency between 250 and 4000 Hz, in 4 frequencies up to the threshold of 30-70 dB NA;
  • Not Protected with AASI in the last year;
  • Being in good health (self report);
  • Present normal vision or corrected vision for normal vision (less than or equal to 20 / 50)
  • Age between 21 and 75 years;
  • Maintain ability to speak, read and write;
  • No evidence of significant accumulation of wax or a foreign body in your external ear canal;

排除标准

  • Presence of acute or chronic limiting diseases;
  • Presence of unilateral or worsening hearing loss in the last 90 days;
  • Blockage of the external ear canal or Ear infection or clogged ear sensation;
  • Otorrhea in the last 90 days;
  • Presence of sudden hearing loss in the last 90 days;
  • Dizziness or vertigo at the time of selection;
  • Presence of any congenital or traumatic deformity of the ear;
  • Presence of pain or discomfort in the ear;
  • Presence of conductive hearing loss or asymmetric hearing loss;
  • Presence of hearing loss that exceeds the limits that can be successfully aided by hearing loss (hearing loss);
  • Presence of air bone GAP greater than or equal to 15 decibels at 500 Hz, 1,000 Hz and 2000 Hz.
  • History of otological diseases or neurological disorders;
  • Individuals who do not speak Portuguese;
  • Any clinically unstable medical condition;
  • Any condition which, in the investigator's opinion, places the participant at unacceptable risk if participating in the study.

研究者

发起方
niversidade de São Paulo

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