AAssessment of the potential for improvement in hearing health. Consumer satisfaction with sound amplification with a new high-performance hearing aid-WHO-Inc compared to existing Digital.

Authors
Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2019
INTERVENTION: 60 subjects with hearing loss who never used a hearing aid will participate in the study. They will undergo a previous auditory evaluation. They will be divided into two groups: Group 1 will consist of 30 subjects who will receive the WHO‐Inc analog hearing aid. for 10 weeks. Group 2 It will be composed of 30 subjects who will receive the digital hearing aid present in the Brazilian market for 10 weeks. At the end of the 10 weeks, participants will undergo tests to evaluate their hearing performance with hearing aids and will respond to questionnaires to assess their level of satisfaction with the product. At this point the groups will be changed. Group 1 will receive the digital hearing aid and Group 2 will receive the WHO‐Inc analog hearing aid. They will also use it for 10 weeks and at the end of 10 weeks will undergo the same auditory evaluation to assess hearing aid performance and will respond to product satisfaction questionnaires. Auditory test to be performed: Sentence recognition test in silence and noise. Questionnaires to be applied: Evaluation Protocol for the Benefit of Hearing Aids‐APHAB; Satisfaction with Amplification in Daily Life (SADL); International Outcome Inventory for Hearing Aids (IOI‐HA) (Portuguese Version), GLASGOW Scale of benefit to the hearing aid; questionnaire on difficulty and limitation associated with auditory localization. Audiometry, Speech Correction of Hearing Impairment Device Hearing Aids Patient Satisfaction CONDITION: hearing health and hearing loss ; Other hearing loss Other hearing loss PRIMARY OUTCOME: It is expected to discover the auditory thresholds and auditory performance of the participants in speech situations with and without the use of hearing aids through the test of speech perception in silence and noise.; It is expected to obtain answers on the level of satisfaction of the participants about the two products tested through the satisfaction questionnaires applied. SECONDARY OUTCOME: Discover patient satisfaction with the two tested sound amplification devices and compare them. ; To discover the performance of the users in the tests of speech perception (silence and noise) using the two technologies; ; Discover the quality and performance of the two technologies in the long term; ; Achieve a high‐tech, low‐cost hearing product for universal health care. It is expected to conclude which hearing aids (analogue of WHO‐Inc. Or the digital of the Brazilian market) will bring greater auditory benefit and greater satisfaction for the participants. INCLUSION CRITERIA: 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;
Epistemonikos ID: 6c5df42a66af165ead65cf6dc03668114e649a6d
First added on: Aug 24, 2024