Healthy heaAring for Healthy Ageing: Data-driven Hearing Rehabilitation Intervention to Promote Healthy Hearing

Summary

The goal of the HAHA trial is to prove that the treatment of HI and prevention of HI-related cognitive decline are most likely to be effective if HI is approached as a broader neurodegenerative entity with multifaceted manifestations currently unaddressed in clinical practice and managed using a novel individualised data-driven protocol for early hearing rehabilitation. The main hypothesis is that, compared with standard care, the data-driven rehabilitation will likely have broader benefits manifested in three key areas: hearing, cognition, and quality of life and psychosocial outcomes.

Participants will be randomized 1:1 to either intervention (individualised data-driven hearing rehabilitation) or control group (standard care hearing rehabilitation). The primary objective of this study is to investigate the effect of an optimized data-driven hearing rehabilitation protocol versus standard care protocol on change in speech perception in noise (SPIN) in older adults with mild to moderately severe sensorineural HI and without dementia.

Conditions

• Sensorineural Hearing Loss
• Cognitive Decline

Interventions

OTHER

Individualised data-driven hearing rehabilitation

HA fittings will be conducted with the Real-Ear Measurements (REM) method that is recommended by the latest ISO-standard (21388:2020) and by the preliminary results of the BREM study at KUH. After the fitting of the HAs, participants' auditory-related outcomes will be immediately assessed using DigiKuulo and re-fitting is performed if needed based on the following criteria: 1. The absolute improvement in the DIN test is less than 1,5dB (SNR), OR 2. The absolute result of the DIN test is more than -8,5 dB (SNR) OR 3. The participant is unsatisfied with the HA fitting Participants are invited to intervention-related monitoring appointments at 3, 6 and 12 months after the primary HA fitting. At these visits, auditory outcomes of the rehabilitation are assessed via DigiKuulo and re-fittings are performed as needed.

OTHER

Standard care hearing rehabilitation

HA will be fitted with automatic algorithms by HA manufacturers and REM-fitting is only applied in complex cases based on the hearing rehabilitator's clinical judgement. Three months after the HA fitting, participants will be contacted via phone call to inquire about the status of the rehabilitation. Additional monitoring visits may be offered based on the participant's feedback. After the 3-month monitoring phone call participants will be advised to further contact the study team if they are dissatisfied with the amplification or for any other problem with their device.

Sponsors & Collaborators

• University of Eastern Finland

  collaborator OTHER

• Kuopio University Hospital

  lead OTHER

Principal Investigators

• Aarno Dietz, prof. · Kuopio University Hospital and University of Eastern Finland

• Alina Solomon, prof. · University of Eastern Finland

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Max Age

84 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-01

Primary Completion

2028-02-29

Completion

2028-02-29

Countries

• Finland

Study Locations