A Prospective Observational Study of Audiological Outcomes, Safety, and Cognitive Function in Elderly Patients and Patients with Failed Tympanoplasty Using the Osia System

A Prospective Observational Study of Audiological Outcomes, Safety, and Cognitive Function in Elderly Patients and Patients with Failed Tympanoplasty Using the Osia System - A Prospective Observational Study of Audiological Outcomes, Safety, and Cognitive Function in Elderly Patients and Patients with Failed Tympanoplasty Using the Osia System

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000061155

Enrollment

Registered

2026-04-03

Start date

2026-04-30

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Conductive hearing loss and mixed hearing loss

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Participants must meet all of the following criteria: Adults aged 20 years or older who are able to understand the study and provide written informed consent Eligible for bone conduction implantation Osia system defined as: Presence of conductive or mixed hearing loss in at least one ear Bone conduction threshold <=55 dB average at 500 1000 2000 and 4000 Hz in the implanted ear Inability to use or insufficient benefit from air conduction bone conduction or cartilage conduction hearing aids Meeting at least one of the following: a. Age >=65 years elderly group

Exclusion criteria

Exclusion criteria: Participants meeting any of the following criteria will be excluded: Hearing loss primarily due to inner ear pathology Severe cognitive impairment that precludes completion of questionnaires Presence of active middle ear infection or cholesteatoma Cranial anatomy or skin condition unsuitable for Osia system implantation Bone thickness less than 3 mm Any other condition deemed inappropriate for study participation by the investigator

Design outcomes

Primary

Measure	Time frame
Change in aided pure-tone average (PTA4 at 0.5, 1, 2, and 4 kHz) at 12 weeks postoperatively compared with baseline	—

Secondary

Measure	Time frame
1.Changes in speech discrimination scores in quiet and noise (SNR +10, +5, 0 dB) at 12, 24, and 48 weeks postoperatively compared with baseline 2.Changes in patient-reported outcomes (SSQ12 and APHAB) at 12, 24, and 48 weeks postoperatively compared with baseline 3.Changes in cognitive function assessed by MoCA at 12, 24, and 48 weeks postoperatively compared with baseline 4.Incidence and severity of postoperative delirium in the acute postoperative period assessed using the Confusion Assessment Method 5.Incidence of postoperative complications (including surgical site infection, skin complications, and magnet-related pressure issues) at 12, 24, and 48 weeks 6.Aided hearing thresholds at 12, 24, and 48 weeks postoperatively	—

Measure

Time frame

1.Changes in speech discrimination scores in quiet and noise (SNR +10, +5, 0 dB) at 12, 24, and 48 weeks postoperatively compared with baseline 2.Changes in patient-reported outcomes (SSQ12 and APHAB) at 12, 24, and 48 weeks postoperatively compared with baseline 3.Changes in cognitive function assessed by MoCA at 12, 24, and 48 weeks postoperatively compared with baseline 4.Incidence and severity of postoperative delirium in the acute postoperative period assessed using the Confusion Assessment Method 5.Incidence of postoperative complications (including surgical site infection, skin complications, and magnet-related pressure issues) at 12, 24, and 48 weeks 6.Aided hearing thresholds at 12, 24, and 48 weeks postoperatively

—

Countries

Japan

Contacts

Public ContactManabu Komori

St. Marianna University School of Medicine Otolaryngology

manabu.komori@marianna-u.ac.jp0449778111

Outcome results