Quality Control of CE-Certified Phonak Hearing Aids - 2019_19

NCT03992989 | Completed

• 1 other identifier: Sonova2019_19
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Phonak Hearing Systems pass through different development and study stages. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing Systems undergo a final quality control in terms of clinical trials. This is a pre-validation study, investigating optimized algorithms, features, functions and wearing comfort. This will be a clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

Conditions

Hearing Loss; Sensorineural Hearing Loss

Outcome Measures

Primary Outcomes (1)

• Speech intelligibility in noise

  The primary objective of this study is to investigate the speech intelligibility in noise of the investigational device alone versus the active comparator. Speech understanding in noise will be evaluated with an objective and validated test procedure, the Outcome measure will be the value of speech intelligibility in percentage at a certain signal to noise ratio.

  1 week

Secondary Outcomes (1)

• Subjective Sound quality perception

  4 weeks

Other Outcomes (2)

• Subjective occlusion effect

  4 weeks

• Sound quality for streamed audio signals

  1 week

Study Arms (2)

Phonak Bolero M90-M

EXPERIMENTAL

The Phonak Bolero M90-M is a Behind-the-Ear Hearing aid with direct connectivity functionality from Phonak which will be fitted to the participants individual Hearing loss

Device: Phonak Bolero M90-M

Roger Select

ACTIVE COMPARATOR

The Roger Select is an accessory which can be connected to a compatible hearing aid. It offers an external microphone which streams signals directly to the connected hearing aid.

Device: Roger Select

Interventions

Phonak Bolero M90-M DEVICE

The Phonak Bolero M90-M is a Behind-the-Ear Hearing aid with direct connectivity functionality from Phonak which will be fitted to the participants individual Hearing loss

Phonak Bolero M90-M

Roger Select DEVICE

The Roger Select is an accessory which can be connected to a compatible hearing aid. It offers an external microphone which streams signals directly to the connected hearing aid.

Roger Select

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult hearing impaired persons (minimum age: 18 years, mild to moderate Hearing loss) without hearing aid experience
• Good written and spoken (Swiss) German language skills
• Healthy outer ear
• Ability to fill in a questionnaire (p/eCRF) conscientiously
• Informed Consent as documented by signature
• owning a compatible smartphone
• Hearing loss in range of N2-N3 (ISO 60118-15)

You may not qualify if:

• Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
• Limited mobility and not in the position to attend weekly appointments in Stäfa (Switzerland)
• Limited ability to describe listening impressions/experiences and the use of the hearing aid
• Inability to produce a reliable hearing test result
• Known psychological problems
• Central hearing disorders

Sponsors & Collaborators

• Sonova AG: lead

Study Sites (1)

Sonova AG

Stäfa, Canton of Zurich, 8712, Switzerland

Location

MeSH Terms

Conditions

Hearing Loss; Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2019
• First Posted: June 20, 2019
• Study Start: June 3, 2019
• Primary Completion: July 6, 2019
• Study Completion: July 6, 2019
• Last Updated: July 30, 2020

Record last verified: 2020-07

Locations

CH (1)