This study wants to identify significant improvement in speech recognition in noise in elderly patients (\>= 65 years) that use HA for the first time and the correlations between the use of the HA and quality of life and cognitive status in elderly patients.
This is a repeated measure, single-subject, prospective observational study. No additional intervention is applied to population of HA recipients. Study subjects who use for the first time unilateral or bilateral hearing aids will be included. Eligible participants are consecutively identified on the HA registry of the Local Unit of the National Health System (NHS). Italian NHS is a welfare system which funds totally or partially the HA costs in selected patients.
An approximate number of 100 individuals will be included. The study design is monocentric and it is conducted at the outpatient service of the ENT Department of the "Saliceto" Hospital.
The test includes language-appropriate materials relative to the participating HA recipient.
The evaluation protocol is designed to coincide with routine clinical visits. Each subject is assessed with the full test-battery and questionnaires that are repeated at each of the two visits: one before the HA fitting (Pre) and one after one year of HA use (Post).
Subjects are enrolled in the clinical investigation only after signing the Patient Informed Consent Form prior to the first assessment (baseline, t0).
During the first assessment (Pre) are carried out this procedures: otoscopy and cleaning of the external auditory canal,- unaided pure tone audiometry, unaided speech audiometry in quiet, Italian version of Oldenburg Satztest (OLSA test) and Montreal Cognitive Assessment (MOCA), Hearing Handicap Inventory in the Elderly Screening test (HHIE-S) and Assessment of Quality of Life (AQoL) questionnaires.
During the second assessment (Post) are carried out: otoscopy and cleaning of the external auditory canal, test of the HA functioning, unaided pure tone audiometry, aided speech audiometry in quiet, Italian version of OLSA test and MOCA, HHIE-S, AQoL and International Outcome Inventory for Hearing Aids (IOI-HA) questionnaires.
The maximum administration time for completion of all measures is estimated to be approximately one hour of which 30 minutes are dedicated to standard self-report forms completed by the HA recipient.
In addition to general healthcare and patient-profile data, a selection of observational clinical assessment tools has been chosen for repeated evaluations to reflect changes in the hearing aid benefit and the overall health status of the elderly individual at post-HA use. These tools are commonly used in audiology and/or geriatric practices and are administered in the appropriate language. All questionnaires are validated for the Italian language.
