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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.

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6fntmd
Enrollment
Unknown
Registered
2019-04-30
Start date
2017-06-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hearing health and hearing loss

Interventions

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 o
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.
Device
E01.370.382.375.060.060

Sponsors

Universidade de São Paulo
Lead Sponsor
Faculdade de Medicina de Ribeirão Preto
Collaborator

Eligibility

Age
21 Years to 75 Years

Inclusion criteria

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;

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Brazil

Contacts

Public ContactBárbara ;Miguel Coró;Hyppolito

Universidade de São Paulo;Universidade de São Paulo

barbaracoro.fono@gmail.com;mahyppo@fmrp.usp.br55(16) 36022860;551636022860

Outcome results

None listed

Source: REBEC (via WHO ICTRP)